Trial Outcomes & Findings for A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer (NCT NCT04137289)

Last Updated: 2025-03-25

Results Overview

Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true drug limiting dose (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD is above 0.5 or at least 15 patients have been treated in phase 1a, of which at least 6 were at the MTD.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

110 participants

Primary outcome timeframe

From cycle 1 Day 1 until the second administration of study treatment (two 14-day treatment cycles).

Results posted on

2025-03-25

Participant Flow

The objectives of this phase 1a/b, open-label, multicenter, dose escalation and dose expansion trial were to explore safety and establish maximum tolerated dose (MTD) of BI 905711 in patients with gastrointestinal cancers, as well as to explore pharmacokinetics, pharmacodynamics, and efficacy. Recruitment for the trial was discontinued during Phase 1b and no PDAC (pancreatic ductal adenocarcinoma) patients were enrolled as originally planned.

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

Participant milestones

Participant milestones
Measure	BI 905711 0.02 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic gastrointestinal (GI) cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.06 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 0.6 mg/kg, QW Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Overall Study STARTED	1	1	7	23	16	23	24	8	7
Overall Study Treated in Phase 1a	1	1	7	8	0	8	8	8	7
Overall Study Treated in Phase 1b	0	0	0	15	16	15	16	0	0
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	7	23	16	23	24	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 905711 0.02 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic gastrointestinal (GI) cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.06 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 0.6 mg/kg, QW Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Overall Study Death	0	0	0	0	0	0	1	0	0
Overall Study Clinical disease progression	0	0	0	4	4	2	5	1	0
Overall Study Lost to Follow-up	0	0	0	1	0	0	0	0	0
Overall Study Adverse Event	0	0	1	0	0	1	0	0	0
Overall Study Lack of clinical benefit	0	0	0	0	0	0	0	0	1
Overall Study Objective disease progression	1	1	6	18	12	20	18	7	6

Baseline Characteristics

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 905711 0.02 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic gastrointestinal (GI) cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=23 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 0.6 mg/kg, QW n=16 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).	BI 905711 1.2 mg/kg, Q2W n=23 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=24 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	Total n=110 Participants Total of all reporting groups
Age, Continuous	59.0 Years n=5 Participants	71.0 Years n=7 Participants	64.3 Years STANDARD_DEVIATION 6.7 • n=5 Participants	56.0 Years STANDARD_DEVIATION 10.1 • n=4 Participants	57.3 Years STANDARD_DEVIATION 10.5 • n=21 Participants	57.7 Years STANDARD_DEVIATION 11.5 • n=8 Participants	63.0 Years STANDARD_DEVIATION 10.9 • n=8 Participants	64.9 Years STANDARD_DEVIATION 7.0 • n=24 Participants	62.4 Years STANDARD_DEVIATION 6.8 • n=42 Participants	59.8 Years STANDARD_DEVIATION 10.4 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	16 Participants n=8 Participants	10 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	47 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants	9 Participants n=21 Participants	7 Participants n=8 Participants	14 Participants n=8 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	63 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants	14 Participants n=21 Participants	18 Participants n=8 Participants	19 Participants n=8 Participants	8 Participants n=24 Participants	7 Participants n=42 Participants	94 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	16 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants	13 Participants n=21 Participants	18 Participants n=8 Participants	18 Participants n=8 Participants	5 Participants n=24 Participants	4 Participants n=42 Participants	80 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants

PRIMARY outcome

Timeframe: From cycle 1 Day 1 until the second administration of study treatment (two 14-day treatment cycles).

Population: MTD evaluation set (MTDS): This included all patients in the treated set (TS) who were not replaced for the MTD determination. The MTDS was used for the primary analyses of drug limiting-toxicities (DLTs) and MTD determination. This analysis was carried out for participants in the Phase 1a part of trial.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=44 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Tolerated Dose (MTD) of BI 905711 in Phase 1a	NA milligram / kilogram (mg/kg) The criteria for reaching the MTD were not fulfilled.	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From cycle 1 Day 1 until the day before cycle 3 Day 1 (two 14-day treatment cycles).

Number of patients with dose-limiting toxicity (DLT) during the MTD evaluation period is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Number of Patients With Dose-limiting Toxicity (DLT) During the MTD Evaluation Period in Phase 1a	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, up to 48 weeks.

Population: Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses. While the protocol specified endpoints separately for Phase 1a/1b, final analysis of most endpoints (except pharmacokinetic and MTD endpoints) were based on the Treated set, with Phase 1a and 1b patients pooled, as seen here. Only participants with available data were analyzed.

Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with measurable disease is reported. This was defined as the best overall response of complete response (CR) or partial response (PR), where best overall response was the best response recorded from the start of the study treatment until the earliest of disease progression, death, or last evaluable tumor assessment and before start of subsequent anticancer therapy.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Confirmed Objective Response (OR) for Phase 1a and Phase 1b Combined	0 Participants Interval 0.0 to 97.5	0 Participants Interval 0.0 to 97.5	0 Participants Interval 0.0 to 45.9	0 Participants Interval 0.0 to 15.4	0 Participants Interval 0.0 to 21.8	0 Participants Interval 0.0 to 15.4	0 Participants Interval 0.0 to 15.4	0 Participants Interval 0.0 to 36.9	0 Participants Interval 0.0 to 41.0

PRIMARY outcome

Timeframe: From the first administration of trial medication until tumor progression or death, whichever occurred first, up to 48 weeks.

Population: Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. This TS was used for both safety and efficacy analyses. Only participants with data were included in analysis and final analysis of PFS was based on the TS, with Phase 1a and Phase 1b patients pooled.

This was evaluated per RECIST 1.1 criteria for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response at each time point was evaluated by target lesion, non-target lesions and new lesions together, according to RECIST 1.1. Objective response (OR) was defined as best overall response of confirmed CR or confirmed PR according to RECIST 1.1.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=16 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Progression-free Survival (PFS)	6.29 weeks Not calculable, as only one participant	18.14 weeks Not calculable, as only one participant	5.71 weeks Interval 1.86 to 6.14	7.36 weeks Interval 5.29 to 12.0	7.43 weeks Interval 7.14 to 8.0	6.14 weeks Interval 4.57 to 8.0	7.14 weeks Interval 5.43 to 12.71	11.43 weeks Interval 4.86 to 20.14	7.43 weeks Interval 4.29 to 8.14

SECONDARY outcome

Timeframe: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Participants in the Phase 1a part were analyzed for this endpoint.

Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1a is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=5 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1a	306 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	492 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	2110 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 16.1	6690 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 18.4	11900 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 29.5	26200 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 24.3	40700 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 22.5	61000 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 26.9	—

SECONDARY outcome

Timeframe: Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with available data were included in the analysis.

Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1a is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=3 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1a	336 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	497 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	2580 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 17.5	7030 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 20.9	10300 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 44.8	31900 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 26.4	47700 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 23.9	50300 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 32.1	—

SECONDARY outcome

Timeframe: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1 .

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Due to premature discontinuation of the trial, no additional patients with pancreatic ductal adenocarcinoma were recruited. Only participants with available data were included in the analysis.

Area under the concentration-time curve (AUC0-336) of BI 905711 during the first cycle in phase 1a is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=5 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the First Cycle in Phase 1a	—	20000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	97500 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 39.5	391000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 50.1	872000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 39.8	1770000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 52.0	3330000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 22.3	4590000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 29.8	—

SECONDARY outcome

Timeframe: Cycle 3: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Due to premature discontinuation of the trial, no additional patients with pancreatic ductal adenocarcinoma were recruited.

Area under the concentration-time curve (AUC0-336) of BI 905711 during the third cycle in phase 1a is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=3 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=5 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Area Under the Concentration-time Curve (AUC0-336) of BI 905711 During the Third Cycle in Phase 1a	—	24500 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for one subject.	104000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 26.8	358000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 37.2	717000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 21.3	1990000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 76.3	3390000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 41.2	3990000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 63.3	—

SECONDARY outcome

Timeframe: Within 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after infusion in cycle 1. For 0.6 mg/kg QW only, there was no 336 hrs timepoint as the next drug was already given after 168 hrs.

Maximum measured plasma concentration (Cmax) of BI 905711 during the first cycle in phase 1b is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=16 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=16 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the First Cycle in Phase 1b	5740 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 31.0	6150 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 31.0	10700 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 36.7	23100 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 26.6	—	—	—	—	—

SECONDARY outcome

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with available data were included in the analysis.

Maximum measured plasma concentration (Cmax) of BI 905711 during the third cycle in phase 1b is reported.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=12 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=10 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=11 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=12 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Measured Plasma Concentration (Cmax) of BI 905711 During the Third Cycle in Phase 1b	5630 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 28.0	6310 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 47.8	13600 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 39.5	23100 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 20.9	—	—	—	—	—

SECONDARY outcome

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with available data were included in the analysis.

Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the first cycle in phase 1b is reported. 11. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=14 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=16 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the First Cycle in Phase 1b	323000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 48.0	302000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 40.6	573000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 55.3	1460000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 50.0	—	—	—	—	—

SECONDARY outcome

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with available data were included in the analysis.

Area under the concentration-time curve (AUC0-336) in plasma of BI 905711 during the third cycle in phase 1b is reported. The AUC calculation includes an extrapolation from 168 hrs to 336 hrs to account for the weekly dosing schedule.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=10 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=11 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=11 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Area Under the Concentration-time Curve (AUC0-336) in Plasma of BI 905711 During the Third Cycle in Phase 1b	354000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 42.9	339000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 48.1	571000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 78.9	1460000 hournanogram/milliliter (hng/mL) Geometric Coefficient of Variation 55.9	—	—	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until the last dose of trial medication plus the residual effect period (REP), up to 358 days.

The number of patients with treatment-emergent adverse events (AEs) is reported, namely, all adverse events occurring between start of treatment and end of the residual effect period (REP). Adverse events that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=23 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=16 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=23 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=24 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Number of Patients With Treatment-emergent Adverse Events (AEs)	1 Participants	1 Participants	5 Participants	22 Participants	16 Participants	23 Participants	20 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: At baseline and every 8 weeks (± 7 days) until progression or start of further treatment for disease, up to 48 weeks.

Radiological (CT scan) tumor shrinkage, defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of the longest diameters of the same set of target lesions according to RECIST 1.1 is reported. Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=20 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=14 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=21 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Maximum Percentage Change From Baseline in the Sum of Target Lesion Diameters	13.6 Percentage change in tumor diameter Standard Deviation NA Not calculable, as only 1 participant	-2.4 Percentage change in tumor diameter Standard Deviation NA Not calculable, as only 1 participant	28.8 Percentage change in tumor diameter Standard Deviation 13.85	20.8 Percentage change in tumor diameter Standard Deviation 28.86	26.6 Percentage change in tumor diameter Standard Deviation 26.43	34.3 Percentage change in tumor diameter Standard Deviation 24.76	18.2 Percentage change in tumor diameter Standard Deviation 25.90	19.3 Percentage change in tumor diameter Standard Deviation 20.93	26.8 Percentage change in tumor diameter Standard Deviation 23.02

SECONDARY outcome

Timeframe: From the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented, up to 48 weeks.

Population: Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. This TS was used for both safety and efficacy analyses. Only participants with data were included in analysis and final analysis of overall response was based on the TS, with phase 1a and phase 1b patients pooled.

The duration of overall response was measured from the time measurement criteria were first met for complete response (CR) / partial response (PR) (whichever was first recorded) until the first date that recurrent or progression disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded in the study) according to RECIST 1.1.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=2 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=2 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=4 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Duration of Overall Response	—	127.0 Days Standard Deviation NA Geometric coefficient of variation could not be calculated for one subject.	—	170.3 Days Standard Deviation 84.5	196.5 Days Standard Deviation 119.5	87.0 Days Standard Deviation 58.0	190.7 Days Standard Deviation 78.7	90.5 Days Standard Deviation 45.5	260.0 Days Standard Deviation NA Geometric coefficient of variation could not be calculated for one subject.

SECONDARY outcome

Timeframe: From the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy, up to 48 weeks.

Population: Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. This TS was used for both safety and efficacy analyses. Only participants with data were included in the analysis and final analysis of patients was based on the TS, with phase 1a and phase 1b patients pooled.

Disease control was defined as complete response (PR), partial response (PR), or stable disease according to RECIST 1.1 from the start of treatment until the earliest of progression disease (PD), death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy. This endpoint analyzed the number of patients meeting this criterion.

Outcome measures

Outcome measures
Measure	BI 905711 0.02mg/kg - 4.8 mg/kg, Q2W n=1 Participants Comprises all dose cohorts during the dose escalation phase (phase 1a). Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration of 0.02mg/kg to 4.8 mg/kg of BI 905711 intravenously on Day 1 of each 14-day cycle.	BI 905711 0.06 mg/kg, Q2W n=1 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=6 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 milligram/kilogram (mg/kg) of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 1.2 mg/kg, Q2W n=15 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=22 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=8 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 Participants Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Disease Control	0 Participants	1 Participants	0 Participants	7 Participants	2 Participants	2 Participants	6 Participants	4 Participants	1 Participants

Adverse Events

BI 905711 0.02 mg/kg, Q2W

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

BI 905711 0.06 mg/kg, Q2W

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

BI 905711 0.2 mg/kg, Q2W

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

BI 905711 0.6 mg/kg, Q2W

Serious events: 14 serious events

Other events: 22 other events

Deaths: 15 deaths

BI 905711 0.6 mg/kg, QW

Serious events: 4 serious events

Other events: 16 other events

Deaths: 6 deaths

BI 905711 1.2 mg/kg, Q2W

Serious events: 7 serious events

Other events: 23 other events

Deaths: 15 deaths

BI 905711 2.4 mg/kg, Q2W

Serious events: 10 serious events

Other events: 19 other events

Deaths: 11 deaths

BI 905711 3.6 mg/kg, Q2W

Serious events: 2 serious events

Other events: 7 other events

Deaths: 7 deaths

BI 905711 4.8 mg/kg, Q2W

Serious events: 1 serious events

Other events: 7 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	BI 905711 0.02 mg/kg, Q2W n=1 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.06 mg/kg, Q2W n=1 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=7 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=23 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 0.6 mg/kg, QW n=16 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).	BI 905711 1.2 mg/kg, Q2W n=23 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=24 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Endocrine disorders Adrenal insufficiency	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Ascites	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Intestinal perforation	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Large intestine perforation	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Nausea	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Fatigue	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders General physical health deterioration	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Pyrexia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Cholestasis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Hepatic failure	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Cellulitis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Infectious pleural effusion	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Liver abscess	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Sepsis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Subcutaneous abscess	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Urinary tract infection	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Urosepsis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood bilirubin increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Ischaemic stroke	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Hydronephrosis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Embolism	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.

Other adverse events

Other adverse events
Measure	BI 905711 0.02 mg/kg, Q2W n=1 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.02 milligram/kilogram (mg/kg) of BI 905711 intravenously on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.06 mg/kg, Q2W n=1 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.06 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.2 mg/kg, Q2W n=7 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 0.6 mg/kg, Q2W n=23 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 0.6 mg/kg, QW n=16 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 0.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every week for 3 weeks and then 1 week off (3 weeks on, 1 week off).	BI 905711 1.2 mg/kg, Q2W n=23 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 1.2 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 2.4 mg/kg, Q2W n=24 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 2.4 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks. Participants in both the dose escalation and dose expansion phases at this dose were pooled together for baseline analysis.	BI 905711 3.6 mg/kg, Q2W n=8 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 3.6 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.	BI 905711 4.8 mg/kg, Q2W n=7 participants at risk Patients with confirmed, advanced unresectable or metastatic GI cancers received a single administration (Cycle 1) and multiple administrations (Cycle 3) of 4.8 mg/kg of BI 905711 intravenously as a powder for solution for infusion, on Day 1 of each 14-day cycle treatment, once every two weeks.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	26.1% 6/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	18.8% 3/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	20.8% 5/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	42.9% 3/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Eye disorders Cataract	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal discomfort	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	26.1% 6/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 2/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	26.1% 6/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	20.8% 5/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Anal incontinence	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Ascites	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Constipation	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	18.8% 3/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 3/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	16.7% 4/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Melaena	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Nausea	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	31.2% 5/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	47.8% 11/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	16.7% 4/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 4/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	26.1% 6/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	20.8% 5/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Asthenia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 3/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Axillary pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Chest pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Chills	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Fatigue	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 2/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 3/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Feeling abnormal	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Malaise	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Oedema peripheral	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 3/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
General disorders Pyrexia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 3/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Cholangitis	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Hepatobiliary disorders Hepatic pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations COVID-19	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	18.8% 3/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Device related infection	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Endometritis	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Fungal infection	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Herpes zoster	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Infections and infestations Pneumonia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	16.7% 4/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	16.7% 4/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood bilirubin increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood creatinine increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Blood sodium decreased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Carcinoembryonic antigen increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations International normalised ratio increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Lipase increased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Lymphocyte count decreased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Red blood cells urine positive	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations Urinary occult blood positive	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations White blood cell count decreased	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Investigations White blood cells urine positive	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	26.1% 6/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	21.7% 5/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	28.6% 2/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 2/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Aphasia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Dizziness	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Headache	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 2/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Neuralgia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Nervous system disorders Taste disorder	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Psychiatric disorders Anxiety	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Psychiatric disorders Insomnia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Psychiatric disorders Panic attack	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Dysuria	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Haematuria	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Renal and urinary disorders Renal failure	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	31.2% 5/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.3% 2/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	17.4% 4/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	8.7% 2/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	16.7% 4/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	25.0% 2/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Skin and subcutaneous tissue disorders Eczema	100.0% 1/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	6.2% 1/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Flushing	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Hypertension	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	13.0% 3/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 2/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.2% 1/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Hypotension	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	4.3% 1/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	12.5% 1/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.
Vascular disorders Peripheral embolism	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/1 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	14.3% 1/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/16 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/23 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/24 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/8 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.	0.00% 0/7 • Up to 358 days. Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711. The TS was used for both safety and efficacy analyses.

Additional Information

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Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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