Trial Outcomes & Findings for A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors) (NCT NCT04147234)

Last Updated: 2025-08-19

Results Overview

The MTD in each arm is defined as the highest dose that is expected to cause less than 25% risk of the true DLT rate being above or equal to 33% during the MTD evaluation period. Estimation of the MTD will be based upon the estimation of the posterior probability of the incidence of DLT in toxicity categories during the MTD evaluation period for all evaluable participants. The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second administration of ezabenlimab or the fourth administration of BI 1387446, whichever occurs first. If the second dose of ezabenlimab or the fourth dose of BI 1387446 is not given, the evaluation period ends 90 days after the last administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).

Results posted on

2025-08-19

Participant Flow

This open-label, multicenter, 2-arm, dose-escalation trial evaluated BI 1387446 administered intratumorally into superficial lesions as a single agent (Arm A) or in combination with intravenous ezabenlimab (Arm B). The primary objectives were to assess safety, determine the maximum tolerated dose for both treatment approaches, and explore preliminary efficacy signals. Patients with progressive disease could cross over to Arm B after completing Cycle 1, provided Arm B is open for recruitment.

All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Arm A: BI 1387446 50 μg Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 100 μg Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 200 μg Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 400 μg Participants received a 400 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Overall Study STARTED	7	8	7	4	6	3	3
Overall Study COMPLETED	0	0	1	0	0	0	0
Overall Study NOT COMPLETED	7	8	6	4	6	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: BI 1387446 50 μg Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 100 μg Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 200 μg Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 400 μg Participants received a 400 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Overall Study Clinical deterioration	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	1	1	0	0	0	0
Overall Study Clinical disease progression	1	3	1	1	0	1	0
Overall Study Objective disease progression	6	4	3	3	5	2	3
Overall Study Adverse Event	0	0	0	0	1	0	0

Baseline Characteristics

Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: BI 1387446 50 μg n=7 Participants Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 100 μg n=8 Participants Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 200 μg n=7 Participants Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm A: BI 1387446 400 μg n=4 Participants Participants received a 400 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg n=7 Participants Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=5 Participants Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg n=4 Participants Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Total n=42 Participants Total of all reporting groups
Age, Customized Arm A	62.0 Years STANDARD_DEVIATION 16.6 • n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	55.3 Years STANDARD_DEVIATION 10.1 • n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	65.0 Years STANDARD_DEVIATION 7.2 • n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	55.3 Years STANDARD_DEVIATION 24.4 • n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	—	—	—	59.7 Years STANDARD_DEVIATION 14.1 • n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).
Age, Customized Arm B	—	—	—	—	48.6 Years STANDARD_DEVIATION 14.3 • n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	57.0 Years STANDARD_DEVIATION 18.6 • n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	47.3 Years STANDARD_DEVIATION 17.5 • n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).	50.9 Years STANDARD_DEVIATION 16.0 • n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover).
Sex/Gender, Customized Arm A- male	5 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	3 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	3 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	15 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Sex/Gender, Customized Arm A- female	2 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	1 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	11 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Sex/Gender, Customized Arm B- male	—	—	—	—	4 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	2 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	10 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Sex/Gender, Customized Arm B- female	—	—	—	—	3 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	1 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	2 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	6 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm A- Hispanic or Latino	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	0 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm A- Not Hispanic or Latino	7 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	8 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	7 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	26 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm B- Hispanic or Latino	—	—	—	—	1 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	1 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm B- Not Hispanic or Latino	—	—	—	—	6 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	5 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	15 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm A - Asian	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	1 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	1 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm A- Native Hawaiian or Other Pacific Islander	1 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	1 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm A - White	6 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	8 Participants n=8 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	6 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	—	—	—	24 Participants n=26 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm B - Asian	—	—	—	—	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm B- Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	0 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.
Race/Ethnicity, Customized Arm B - White	—	—	—	—	7 Participants n=7 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	5 Participants n=5 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	4 Participants n=4 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.	16 Participants n=16 Participants • Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication.

PRIMARY outcome

Timeframe: From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).

Population: The MTD set includes all treated participants evaluable per the clinical trial protocol. This covers those completing required BI 1387446 (and ezabenlimab in Arm B) doses in Cycle 1 and undergoing the Echo/MUGA scan at Cycle 2 Visit 1. Patients stopping due to dose-limiting toxicities are still evaluable. Crossover participants from Arm A to B are included only if evaluable in Arm A. Replaced participants during MTD evaluation are excluded.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg n=21 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg n=10 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Maximum Tolerated Dose (MTD) Based on Number of Dose-limiting Toxicities (DLTs)	NA μg (microgram) The maximum tolerated dose (MTD) was not reached in either treatment arm. According to the Bayesian Logistic Regression Model (BLRM) analysis, all explored dose levels formally met the overdosing criterion, meaning the probability of their dose-limiting toxicity (DLT) rate exceeding 33% was below 25%.	—	—	NA μg (microgram) The maximum tolerated dose (MTD) was not reached in either treatment arm. According to the Bayesian Logistic Regression Model (BLRM) analysis, all explored dose levels formally met the overdosing criterion, meaning the probability of their dose-limiting toxicity (DLT) rate exceeding 33% was below 25%.	—	—	—

PRIMARY outcome

Timeframe: From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).

The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second administration of ezabenlimab or the fourth administration of BI 1387446, whichever occurs first. If the second dose of ezabenlimab or the fourth dose of BI 1387446 is not given, the evaluation period ends 90 days after the last administration.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg n=6 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=3 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg n=3 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg n=5 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=6 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg n=4 Participants Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg n=4 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Number of Patients With DLT in the MTD Evaluation Period	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	1 Number of participants	0 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: From start of treatment up to the earliest of progression, death or end of trial (up to 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of any study medication. Due to a protocol amendment, only participants who consented under CTP versions 1 and 2 were analyzed for this endpoint. Participants enrolled under CTP version ≥ 3 were assessed using itRECIST and therefore excluded. As a result, the number of participants analyzed for this endpoint is lower than the total in the treated set.

Objective response, as defined by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), in accordance with Clinical Trial Protocol (CTP) Version 1 and 2, will be presented in terms of the objective response rate (ORR). The ORR is the proportion of patients whose best overall response is a confirmed complete response (CR) or partial response (PR). This determination is based on the investigator's assessment according to RECIST 1.1 criteria, from the date of the first treatment administration until the earliest occurrence of any of the following events: disease progression, death, the last evaluable tumor assessment before the initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover). Their best overall response is counted, regardless of whether it occurred before or after the crossover.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg n=7 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=2 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg n=8 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=4 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg n=7 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Objective Response Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	—	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0	—	0 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of any study medication. Due to a protocol amendment, only participants who consented under CTP version ≥ 3 were analyzed for this endpoint. Participants enrolled under CTP versions 1 and 2 were assessed using RECIST 1.1 and therefore excluded. As a result, the number of participants analyzed for this endpoint is lower than the total in the treated set.

Objective Response based on Response Criteria for Intratumoural Immunotherapy in Solid Tumours (itRECIST): (CTP version 3 and later) Objective response (OR) by itRECIST will be presented in terms of objective response rate (ORR), which is defined as the rate of patients whose best overall response is confirmed itCR or itPR as determined by the Investigator's assessment according to itRECIST from date of first treatment administration until the earliest of confirmed disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent. Cross-over patients are shown in both Arm A (reflecting their initial treatment) and Arm B (reflecting their first treatment post-crossover). Their best overall response is counted, regardless of whether it occurred before or after the crossover.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=3 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg n=4 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=3 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg n=4 Participants Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Objective Response Based on Response Criteria for Intratumoural Immunotherapy in Solid Tumours (itRECIST)	—	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.6 to 80.6	—	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.6 to 80.6	—

SECONDARY outcome

Timeframe: From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of study medication and had both a baseline and at least one post-baseline tumor assessment. Data for this endpoint was collected and evaluated only for participants enrolled under CTP versions 1 and 2 using RECIST 1.1. In these versions, injection of target lesions was not permitted; therefore, injected lesions were collected and assessed separately from target lesions.

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of injected lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of injected lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP v1 and v2 using RECIST 1.1), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Cross-over patients appear in both Arm A (initial treatment) and Arm B (post-crossover treatment). Their best overall response is counted, regardless of timing. Negative values indicate a reduction in injected lesion diameters; positive values indicate an increase.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg n=7 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=2 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg n=6 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=2 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg n=6 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Best Percentage Change From Baseline in Size of Injected Lesions (CTP Version 1 or 2)	23.36 Percent change Standard Deviation 28.94	13.33 Percent change Standard Deviation 18.86	—	-20.73 Percent change Standard Deviation 21.95	-2.78 Percent change Standard Deviation 3.93	—	0.54 Percent change Standard Deviation 19.24

SECONDARY outcome

Timeframe: From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of any study medication. Only participants with both a baseline and at least one post-baseline tumor assessment were included in the analysis. Due to a protocol amendment, disease progression for participants consented under CTP version 1 and 2 was assessed using RECIST1.1 and therefore excluded from this endpoint. As a result, the number of participants analyzed is lower than the total number in the treated set.

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of injected target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of injected target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP version 3 and later using itRECIST), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Negative values indicate reduced lesion diameters; positive values indicate increases. Cross-over patients are included in Arm A (initial treatment) and Arm B (first post-crossover treatment), with their best response counted regardless of timing.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=3 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg n=4 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=3 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg n=4 Participants Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Best Percentage Change From Baseline in Size of Injected Target Lesions (CTP v3.0 or Later Versions)	—	-17.43 Percent change Standard Deviation 39.39	-16.93 Percent change Standard Deviation 58.42	—	-6.67 Percent change Standard Deviation 11.66	-37.76 Percent change Standard Deviation 52.67	—

SECONDARY outcome

Timeframe: From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of any study medication. Only participants with both a baseline and at least one post-baseline tumor assessment were included in the analysis. Due to a protocol amendment, disease progression for participants consented under CTP version ≥ 3 was assessed using itRECIST and therefore excluded from this endpoint. As a result, the number of participants analyzed is lower than the total number in the treated set.

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP v1 and v2 using RECIST 1.1), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. Cross-over patients appear in both Arm A (initial treatment) and Arm B (post-crossover treatment). Their best overall response is counted, regardless of timing. Negative values indicate a reduction in lesion diameters; positive values indicate an increase.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg n=7 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=2 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg n=6 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=2 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg n=7 Participants Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Best Percentage Change From Baseline in Size of Target Lesions (CTP Version 1 or 2)	-0.07 Percent change Standard Deviation 13.92	0.25 Percent change Standard Deviation 0.36	—	1.02 Percent change Standard Deviation 6.89	-0.10 Percent change Standard Deviation 7.58	—	0.07 Percent change Standard Deviation 13.98

SECONDARY outcome

Timeframe: From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).

Population: Treated Set (TS): This set included all participants who received at least one dose of study medication and had both a baseline and at least one post-baseline tumor assessment. Data for this endpoint was collected and evaluated only for participants enrolled under CTP version 3 and later using itRECIST, as these protocol versions allowed injection of target lesions.

This endpoint evaluated the best percentage change (i.e., greatest reduction) in the size of non-injected target lesions from baseline (the first measurement at the start of treatment) over time. The best percentage change from baseline in the size of non-injected target lesions was analyzed using descriptive statistics. All lesion measurements recorded from the start of trial treatment until the earliest of the following were considered: disease progression (assessed under CTP version 3 and later using itRECIST), initiation of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

Outcome measures

Outcome measures
Measure	Arm A: BI 1387446 50 μg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 100 μg / Ezabenlimab 240 mg n=3 Participants Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm B: BI 1387446 200 μg / Ezabenlimab 240 mg n=4 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	Arm A: BI 1387446 100 μg Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 200 μg n=3 Participants Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm A: BI 1387446 400 μg n=4 Participants Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.	Arm B: BI 1387446 50 μg / Ezabenlimab 240 mg Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Best Percentage Change From Baseline in Size of Non-injected Target Lesions (CTP v3.0 or Later Versions)	—	13.42 Percent change Standard Deviation 14.14	-17.28 Percent change Standard Deviation 25.17	—	-6.23 Percent change Standard Deviation 6.23	1.30 Percent change Standard Deviation 22.35	—

Adverse Events

BI 1387446 50 ug

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

BI 1387446 100 ug

Serious events: 4 serious events

Other events: 8 other events

Deaths: 2 deaths

BI 1387446 200 ug

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

BI 1387446 400 ug

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

BI 1387446 50 ug / Ezabenlimab 240 mg

Serious events: 5 serious events

Other events: 7 other events

Deaths: 2 deaths

BI 1387446 100 ug / Ezabenlimab 240 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

BI 1387446 200 ug / Ezabenlimab 240 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	BI 1387446 50 ug n=7 participants at risk Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 100 ug n=8 participants at risk Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 200 ug n=7 participants at risk Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 400 ug n=4 participants at risk Participants received a 400 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 50 ug / Ezabenlimab 240 mg n=7 participants at risk Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	BI 1387446 100 ug / Ezabenlimab 240 mg n=5 participants at risk Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	BI 1387446 200 ug / Ezabenlimab 240 mg n=4 participants at risk Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Blood and lymphatic system disorders Splenic vein thrombosis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Hepatobiliary disorders Liver disorder	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Pneumonia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Sepsis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Injury, poisoning and procedural complications Injury	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	42.9% 3/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Carotid artery stenosis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Dizziness	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Syncope	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Product Issues Device occlusion	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Deep vein thrombosis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).

Other adverse events

Other adverse events
Measure	BI 1387446 50 ug n=7 participants at risk Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 100 ug n=8 participants at risk Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 200 ug n=7 participants at risk Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 400 ug n=4 participants at risk Participants received a 400 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. The injection volume was based on tumor diameter.	BI 1387446 50 ug / Ezabenlimab 240 mg n=7 participants at risk Participants received a 50 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	BI 1387446 100 ug / Ezabenlimab 240 mg n=5 participants at risk Participants received a 100 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.	BI 1387446 200 ug / Ezabenlimab 240 mg n=4 participants at risk Participants received a 200 μg intratumoral injection of BI 1387446 under visual inspection for visible skin tumors or imaging guidance for non-visible tumors on Day 1 of a 21-day treatment cycle. BI 754091 (ezabenlimab) was administered intravenously at the recommended Phase II dose of 240 mg once every 21-day cycle, with a maximum treatment duration of 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	37.5% 3/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	40.0% 2/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	50.0% 2/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Blood and lymphatic system disorders Neutropenia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Cardiac disorders Bradycardia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Ear and labyrinth disorders Cerumen impaction	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Endocrine disorders Hyperthyroidism	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Endocrine disorders Hypothyroidism	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Eye disorders Cataract	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Eye disorders Dry eye	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Eye disorders Vision blurred	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Constipation	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	40.0% 2/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Dry mouth	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Dysphagia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Gastritis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Haemorrhoidal haemorrhage	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Nausea	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	37.5% 3/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	40.0% 2/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Subileus	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Gastrointestinal disorders Vomiting	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Asthenia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	40.0% 2/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	75.0% 3/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Axillary pain	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Chest pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Chills	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Face oedema	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Facial pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Fatigue	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	50.0% 4/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Injection site induration	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Injection site inflammation	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Injection site pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Injection site reaction	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Localised oedema	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Mucosal discolouration	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Oedema peripheral	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Pain	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Peripheral swelling	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
General disorders Pyrexia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	50.0% 2/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Hepatobiliary disorders Hyperbilirubinaemia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Immune system disorders Allergic oedema	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Immune system disorders Drug hypersensitivity	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations COVID-19	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Cellulitis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Cystitis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Fungal skin infection	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Lower respiratory tract infection	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Oral candidiasis	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Otitis media	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Respiratory tract infection	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Infections and infestations Urinary tract infection	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Injury, poisoning and procedural complications Nerve injury	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Injury, poisoning and procedural complications Wound secretion	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Alanine aminotransferase increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Aspartate aminotransferase increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Blood bicarbonate decreased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Blood bilirubin increased	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Gamma-glutamyltransferase increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Heart rate increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Hypophonesis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Platelet count decreased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Troponin T increased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Investigations Weight decreased	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypokalaemia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Muscle swelling	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Muscular weakness	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Musculoskeletal and connective tissue disorders Pain in jaw	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	50.0% 2/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Dizziness	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 2/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Headache	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Paraesthesia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Parkinson's disease	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Sciatica	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Somnolence	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Nervous system disorders Syncope	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Psychiatric disorders Anxiety	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Psychiatric disorders Depression	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Psychiatric disorders Insomnia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Renal and urinary disorders Chromaturia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	20.0% 1/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Blister	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	25.0% 1/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Haemorrhage	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Hypertension	28.6% 2/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Hypotension	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Lymphoedema	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Orthostatic hypotension	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	14.3% 1/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).
Vascular disorders Pallor	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	12.5% 1/8 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/7 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/5 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).	0.00% 0/4 • AE Collection Period: Arm A: From the first BI 1387446 dose until 90 days after the last dose (Residual Effect Period), or until the first Arm B dose, whichever occurred first - for a total duration of up to 14.8 months. Arm B: From the first trial drug dose until 90 days after the last dose (REP), for a total duration of up to 16.4 months. All-Cause Mortality: From the first trial drug dose plus 6 months follow-up after the last dose for a total duration of up to 19.4 months. Treated set (TS): This patient set includes all patients who were documented to have received at least one dose of any study medication. Cross-over patients are depicted both in Arm A (contributing to the patient's initial treatment in Arm A) and Arm B (contributing to the treatment the patient received first after the crossover to Arm B).

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 018002430127

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER