Trial Outcomes & Findings for BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours (NCT NCT02273388)

NCT ID: NCT02273388

Last Updated: 2023-10-03

Results Overview

MTD is defined as: the dose of BI 6727 which is one dose tier below that dose at which two or more out of a maximum of six patients experienced dose-limiting toxicity (DLT). At the maximum tolerated dose, no more than one patient out of six patients may experience DLT, i.e. MTD is defined as the highest dose studied for which the incidence of dose-limiting toxicity is no more than 17% (i.e. 1/6 patients) during the first course. DLT is defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or 4 non haematological toxicity (except emesis or diarrhoea responding to supportive treatment), or drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection, or CTCAE Grade 4 thrombocytopenia .

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 65 participants
• Primary outcome timeframe: 21 days (first treatment course).
• Results posted on: 2023-10-03

Participant Flow

An open label, uncontrolled "first in man" dose escalation trial in patients with advanced solid tumours with repeated administration in patients with clinical benefit.

All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.

Participant milestones

Measure	12 mg BI 6727 12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Overall Study STARTED	4	3	3	2	4	3	15	8	6	5	10	2
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	3	2	4	3	15	8	6	5	10	2

Reasons for withdrawal

Measure	12 mg BI 6727 12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Overall Study Adverse Event	0	0	0	0	0	0	1	2	0	0	0	0
Overall Study Adverse Event study disease worse	4	3	3	2	4	3	14	6	6	5	10	1
Overall Study Sponsor decision	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

Baseline characteristics by cohort

Measure	12 mg BI 6727 n=4 Participants 12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	Total n=65 Participants Total of all reporting groups
Age, Continuous	34.5 Years n=5 Participants	53.0 Years n=7 Participants	43.0 Years n=5 Participants	57.0 Years n=4 Participants	58.5 Years n=21 Participants	65.0 Years n=10 Participants	55.0 Years n=115 Participants	54.5 Years n=24 Participants	60.5 Years n=42 Participants	61.0 Years n=42 Participants	60.0 Years n=42 Participants	50.0 Years n=42 Participants	58.0 Years n=36 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	6 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	0 Participants n=42 Participants	27 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants	7 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	38 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	15 Participants n=115 Participants	8 Participants n=24 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	10 Participants n=42 Participants	2 Participants n=42 Participants	65 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: 21 days (first treatment course).

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

MTD is defined as: the dose of BI 6727 which is one dose tier below that dose at which two or more out of a maximum of six patients experienced dose-limiting toxicity (DLT). At the maximum tolerated dose, no more than one patient out of six patients may experience DLT, i.e. MTD is defined as the highest dose studied for which the incidence of dose-limiting toxicity is no more than 17% (i.e. 1/6 patients) during the first course.

DLT is defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or 4 non haematological toxicity (except emesis or diarrhoea responding to supportive treatment), or drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection, or CTCAE Grade 4 thrombocytopenia .

Outcome measures

Measure	BI 6727 n=65 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Maximum Tolerated Dose (MTD)	400 Milligram (mg)	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first drug administration until last drug administration plus 21 days, up to 835 days.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

Number of participants with adverse events. The events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3.0.

Grade refers to the severity of adverse event. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Number of Participants With Adverse Events (AEs) Grade 5	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Grade 1	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Grade 2	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants	6 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Grade 3	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	3 Participants	2 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline to the last value on treatment, up to 814 days.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

Number of participants with clinically relevant abnormalities, occurring in >5% of the total number of participants, is reported.

Clinically relevant post baseline values with Common Terminology Criteria for Adverse Events (CTCAE) grades:

• CTCAE grade ≥4 for White blood cell count (WBC) , Neutrophils (NEUT), NEUABS Lymphocytes (LMPH) if baseline CTCAE grade is not 4
• CTCAE grade ≥3 for Haemoglobin (HGB), Platelets count (PLTCT), Alkaline phosphatase (ALKP), serum glutamic-oxaloacetic-transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), total bilirubin (TBILI), if baseline CTCAE grade is ≥3 increases of one grade
• CTCAE grade ≥2 for other parameters, if baseline CTCAE grade is ≥2 increases of at least one grade

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Number of Participants With Clinically Relevant Abnormalities Haematocrit	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	10 Participants	4 Participants	2 Participants	4 Participants	7 Participants	1 Participants
Number of Participants With Clinically Relevant Abnormalities Haemoglobin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormalities Mean corpuscular volume (MCV)	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Clinically Relevant Abnormalities Platelets	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	4 Participants	2 Participants
Number of Participants With Clinically Relevant Abnormalities Red blood cell count (RBC)	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants	7 Participants	4 Participants	1 Participants	3 Participants	4 Participants	2 Participants
Number of Participants With Clinically Relevant Abnormalities White blood cell count (WBC)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormalities Neutrophils	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	2 Participants	6 Participants	2 Participants
Number of Participants With Clinically Relevant Abnormalities Sodium	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormalities Alkaline phosphatase	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormalities Lactate dehydrogenase (LDH)	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Clinically Relevant Abnormalities Albumin	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	5 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Clinically Relevant Abnormalities Creatinine	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Relevant Abnormalities Glucose	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline and at end of treatment (up to 814 days).

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

ECOG score: The scale of ECOG score is defined as a six point categorical scale as described ranging from 0 (asymptomatic) to 5 (death). ECOG score change from baseline to end of treatment is calculated, and defined as

= ECOG score at end of treatment - ECOG score at baseline.

Scale of ECOG score change:

The ECOG score changes from baseline score are categorized on a three point categorical scale: Improved, unchanged, and deteriorated. Improvement or deterioration of performance status required a decrease or an increase from baseline, respectively, of at least one point on the ECOG scale. The number of patients per category ("improved", "unchanged", "deteriorated" "unknown") is reported.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score Improved	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score Unchanged	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	7 Participants	2 Participants	2 Participants	3 Participants	2 Participants	0 Participants
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score Deteriorated	2 Participants	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants	7 Participants	5 Participants	4 Participants	2 Participants	8 Participants	2 Participants
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline and 5 minutes before infusion end, 1 hour after end of infusion and at 4 and 12 hours after start of infusion, at course 1.

Population: QT extension cohort: Patients treated with 300 mg BI6727 to investigate QTc changes, according to two different treatment schedules in course 1 and course 2, (300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h). Results are reported for 300 mg over 1 hour infusion vs. 300 mg over 2 hours infusion. Only participants with non-missing data were included in the analysis.

Electrocardiogram (ECG) - QTcF change from baseline. QTcF intervals form the ECGs were analysed for changes during and after intravenous infusion of BI 300 mg dose over 1 hours and over 2 hours. For baseline ECG, the combined baseline, defined as the mean of the 2 triplicates at the time-point closest to but prior to the start of the infusion of both treatment courses, i.e. a common baseline is used for both treatment courses, was used. Mean is adjusted mean.

Abbreviations:

QTcF: QT interval, corrected for heart rate according to Fridericia's formula (seconds) = measured QT / (cube root of preceding RR interval) QT: Interval from the beginning of the Q wave to the end of the T wave on an ECG (seconds).

CfB: Change from baseline.

Outcome measures

Measure	BI 6727 n=13 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=11 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Electrocardiogram (ECG) - QTcF Change From Baseline CfB to 5 minutes before infusion end	17.79 Millisecond (ms) Interval 13.68 to 21.9	13.23 Millisecond (ms) Interval 8.83 to 17.64	—	—	—	—	—	—	—	—	—	—
Electrocardiogram (ECG) - QTcF Change From Baseline CfB to 1 hours after infusion end	13.99 Millisecond (ms) Interval 9.88 to 18.1	6.84 Millisecond (ms) Interval 2.44 to 11.25	—	—	—	—	—	—	—	—	—	—
Electrocardiogram (ECG) - QTcF Change From Baseline CfB to 4 hours after infusion start	10.65 Millisecond (ms) Interval 6.54 to 14.76	7.08 Millisecond (ms) Interval 2.67 to 11.48	—	—	—	—	—	—	—	—	—	—
Electrocardiogram (ECG) - QTcF Change From Baseline CfB to 24 hours after infusion start	4.33 Millisecond (ms) Interval 0.22 to 8.44	-4.33 Millisecond (ms) Interval -8.73 to 0.07	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At baseline.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

Systolic blood pressure and diastolic blood pressure are reported.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Vital Signs - Blood Pressure Systolic blood pressure	126 Millimeter of mercury (mmHg) Interval 110.0 to 155.0	124 Millimeter of mercury (mmHg) Interval 107.0 to 148.0	124 Millimeter of mercury (mmHg) Interval 110.0 to 134.0	112 Millimeter of mercury (mmHg) Interval 100.0 to 124.0	110 Millimeter of mercury (mmHg) Interval 99.0 to 131.0	130 Millimeter of mercury (mmHg) Interval 116.0 to 164.0	125 Millimeter of mercury (mmHg) Interval 102.0 to 172.0	129 Millimeter of mercury (mmHg) Interval 100.0 to 146.0	148 Millimeter of mercury (mmHg) Interval 120.0 to 165.0	135 Millimeter of mercury (mmHg) Interval 110.0 to 149.0	144 Millimeter of mercury (mmHg) Interval 88.0 to 178.0	129 Millimeter of mercury (mmHg) Interval 128.0 to 130.0
Vital Signs - Blood Pressure Diastolic blood pressure	74 Millimeter of mercury (mmHg) Interval 60.0 to 80.0	80 Millimeter of mercury (mmHg) Interval 68.0 to 90.0	78 Millimeter of mercury (mmHg) Interval 78.0 to 85.0	75 Millimeter of mercury (mmHg) Interval 70.0 to 80.0	71.5 Millimeter of mercury (mmHg) Interval 58.0 to 80.0	76 Millimeter of mercury (mmHg) Interval 72.0 to 90.0	80 Millimeter of mercury (mmHg) Interval 69.0 to 98.0	78.5 Millimeter of mercury (mmHg) Interval 67.0 to 89.0	86.5 Millimeter of mercury (mmHg) Interval 60.0 to 100.0	82 Millimeter of mercury (mmHg) Interval 70.0 to 90.0	81.5 Millimeter of mercury (mmHg) Interval 45.0 to 100.0	75 Millimeter of mercury (mmHg) Interval 70.0 to 80.0

SECONDARY outcome

Timeframe: At baseline.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

Pulse rate is reported.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Vital Signs - Pulse Rate	88 Beats per minute (bpm) Interval 76.0 to 92.0	80 Beats per minute (bpm) Interval 72.0 to 98.0	88 Beats per minute (bpm) Interval 73.0 to 92.0	92 Beats per minute (bpm) Interval 88.0 to 96.0	91 Beats per minute (bpm) Interval 84.0 to 99.0	88 Beats per minute (bpm) Interval 66.0 to 96.0	78 Beats per minute (bpm) Interval 64.0 to 120.0	84 Beats per minute (bpm) Interval 59.0 to 97.0	75 Beats per minute (bpm) Interval 58.0 to 104.0	76 Beats per minute (bpm) Interval 67.0 to 100.0	82 Beats per minute (bpm) Interval 62.0 to 114.0	76 Beats per minute (bpm) Interval 74.0 to 78.0

SECONDARY outcome

Timeframe: Up to 814 days.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

For solid tumours, evaluation of tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) definition. The overall response of target and non-target lesions together with or without the appearance of new lesions as reported by the investigator was assessed on a four point categorical scale as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the RECIST criteria. In order to best handle measurements that were non-evaluable (NEV) a modified version of the RECIST criteria was used. If a RECIST overall response was deemed NEV, it could be further classified into non-evaluable clinically progressive disease (NEVCPD ) or non-evaluable clinically non-progressive disease (NEVCNPD), depending on the subjective assessment of the investigator.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Number of Participants With Unconfirmed Best Overall Response Progressive Disease (PD) or NEVCPD	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants	8 Participants	3 Participants	4 Participants	4 Participants	3 Participants	0 Participants
Number of Participants With Unconfirmed Best Overall Response Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Unconfirmed Best Overall Response Non-evaluable, clinically non-progressive disease (NEVCNPD)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Unconfirmed Best Overall Response Complete response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Unconfirmed Best Overall Response Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Unconfirmed Best Overall Response Stable disease	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	7 Participants	4 Participants	2 Participants	1 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 814 days.

Population: Treated Set (TS): All patients who received at least one dose of BI 6727.

Number of participants with progression of disease.

Progressive disease is defined according to the Response Evaluation Criteria in Solid Tumours (RECIST) as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter.

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Number of Participants With Progression	3 Participants	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	15 Participants	7 Participants	6 Participants	5 Participants	10 Participants	1 Participants

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Treated Set (TS): All patients who received at least one dose of BI 6727. Only patients with non-missing values were included in the analysis.

Maximum concentration of BI 6727 in plasma (Cmax).

Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h:

For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1*, 2, 4, 8, 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1*, 2, 3, 4 and 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Maximum Concentration of BI 6727 in Plasma (Cmax)	18.8 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 14.3	50.7 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 12.4	91.1 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 17.6	169.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 11.7	234.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 30.9	470.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 57.6	758 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 28.8	519.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 60.3	246.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 68.8	724.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 23.6	1020.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 20.9	1450.0 Nanogram/ Milliliter (ng/mL) Geometric Coefficient of Variation 8.81

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Treated Set (TS): All patients who received at least one dose of BI 6727. Only patients with non-missing values were included in the analysis.

Time from dosing to maximum concentration (tmax).

Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h:

For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1*, 2, 4, 8, 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1*, 2, 3, 4 and 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Time From Dosing to Maximum Concentration (Tmax)	0.667 Hours (h) Interval 0.5 to 0.75	0.750 Hours (h) Interval 0.75 to 1.25	0.500 Hours (h) Interval 0.25 to 0.533	0.884 Hours (h) Interval 0.767 to 1.0	0.533 Hours (h) Interval 0.5 to 0.733	1.00 Hours (h) Interval 0.5 to 1.03	0.750 Hours (h) Interval 0.5 to 1.0	1.00 Hours (h) Interval 0.967 to 1.01	2.00 Hours (h) Interval 1.98 to 2.0	0.750 Hours (h) Interval 0.75 to 0.867	0.750 Hours (h) Interval 0.25 to 1.0	0.517 Hours (h) Interval 0.25 to 0.783

SECONDARY outcome

Timeframe: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 and 504 hours after start of infusion. (*Immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Area under the concentration-time curve of BI 6727 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Area Under the Concentration-time Curve of BI 6727 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	149 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 31.6	380 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 38.9	778 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 25.1	1270 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 7.64	2140 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 27.9	5670 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 36.7	6540 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 32.6	—	—	10000 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 57.6	7510 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 19.3	10900 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 14.0

SECONDARY outcome

Timeframe: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 and 504 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Treated Set (TS): All patients who received at least one dose of BI 6727. Only patients with non-missing values were included in the analysis.

Area under the concentration-time curve of BI 6727 in plasma over the time interval from 0 to the last quantifiable time point tz (AUC0-tz).

Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h:

For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1*, 2, 4, 8, 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1*, 2, 3, 4 and 24 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Area Under the Concentration-time Curve of BI 6727 in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point tz (AUC0-tz)	101 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 39.0	320 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 52.0	636 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 25.8	1110 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 15.9	1800 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 20.6	4780 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 20.0	5680 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 26.4	2420 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 52.3	1730 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 53.7	8230 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 37.1	6990 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 18.5	10300 Nanogram * Hours / Milliliter (ng*h/mL) Geometric Coefficient of Variation 15.7

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Terminal rate constant in plasma (λz).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Terminal Rate Constant in Plasma (λz)	0.00715 1 / hour Geometric Coefficient of Variation 32.0	0.00649 1 / hour Geometric Coefficient of Variation 16.9	0.00446 1 / hour Geometric Coefficient of Variation 40.1	0.00552 1 / hour Geometric Coefficient of Variation 28.9	0.00454 1 / hour Geometric Coefficient of Variation 30.7	0.00464 1 / hour Geometric Coefficient of Variation 49.4	0.00658 1 / hour Geometric Coefficient of Variation 27.2	—	—	0.00582 1 / hour Geometric Coefficient of Variation 37.6	0.00784 1 / hour Geometric Coefficient of Variation 49.2	0.00688 1 / hour Geometric Coefficient of Variation 20.4

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Terminal half-life of the analyte in plasma (t1/2).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Terminal Half-life of the Analyte in Plasma (t1/2)	96.9 Hours (h) Geometric Coefficient of Variation 32.0	107 Hours (h) Geometric Coefficient of Variation 16.9	156 Hours (h) Geometric Coefficient of Variation 40.1	126 Hours (h) Geometric Coefficient of Variation 28.9	153 Hours (h) Geometric Coefficient of Variation 30.7	149 Hours (h) Geometric Coefficient of Variation 49.4	105 Hours (h) Geometric Coefficient of Variation 27.2	—	—	119 Hours (h) Geometric Coefficient of Variation 37.6	88.4 Hours (h) Geometric Coefficient of Variation 49.2	101 Hours (h) Geometric Coefficient of Variation 20.4

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Mean residence time of BI 6727 in the body after intravenous administration (MRT).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Mean Residence Time of BI 6727 in the Body After Intravenous Administration (MRT)	113 Hours (h) Geometric Coefficient of Variation 33.6	127 Hours (h) Geometric Coefficient of Variation 11.3	174 Hours (h) Geometric Coefficient of Variation 36.2	137 Hours (h) Geometric Coefficient of Variation 40.4	164 Hours (h) Geometric Coefficient of Variation 29.6	139 Hours (h) Geometric Coefficient of Variation 74.1	99.5 Hours (h) Geometric Coefficient of Variation 38.7	—	—	131 Hours (h) Geometric Coefficient of Variation 62.4	82.5 Hours (h) Geometric Coefficient of Variation 43.5	88.1 Hours (h) Geometric Coefficient of Variation 5.99

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Total clearance of BI 6727 in the plasma after intravascular adminstration (CL).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Total Clearance of BI 6727 in the Plasma After Intravascular Adminstration (CL)	1140 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 32.2	876 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 44.4	924 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 20.2	918 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 9.17	947 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 23.4	547 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 28.8	762 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 32.6	—	—	583 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 57.6	885 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 19.4	689 Milliliter/Minute (mL/min) Geometric Coefficient of Variation 14.0

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Apparent volume of distribution at steady state following intravascular administration (Vss).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)	7730 Liter Geometric Coefficient of Variation 30.8	6670 Liter Geometric Coefficient of Variation 46.0	9630 Liter Geometric Coefficient of Variation 36.7	7520 Liter Geometric Coefficient of Variation 50.9	9320 Liter Geometric Coefficient of Variation 13.3	4580 Liter Geometric Coefficient of Variation 41.2	4450 Liter Geometric Coefficient of Variation 37.1	—	—	4570 Liter Geometric Coefficient of Variation 19.8	4380 Liter Geometric Coefficient of Variation 49.3	3640 Liter Geometric Coefficient of Variation 20.1

SECONDARY outcome

Timeframe: At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).

Population: Only patients in the treated set who had non-missing values were included in the analysis. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data.

Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Apparent Volume of Distribution During the Terminal Phase λz Following an Intravascular Dose (Vz)	9530 Liter (L) Geometric Coefficient of Variation 34.8	8100 Liter (L) Geometric Coefficient of Variation 52.6	12400 Liter (L) Geometric Coefficient of Variation 46.2	9980 Liter (L) Geometric Coefficient of Variation 38.8	12500 Liter (L) Geometric Coefficient of Variation 15.1	7070 Liter (L) Geometric Coefficient of Variation 19.4	6940 Liter (L) Geometric Coefficient of Variation 38.0	—	—	6010 Liter (L) Geometric Coefficient of Variation 28.1	6770 Liter (L) Geometric Coefficient of Variation 54.7	6000 Liter (L) Geometric Coefficient of Variation 35.1

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 24 hours after the infusion.

Population: Only patients in the treated set (TS) who had non-missing values were included in the analysis. Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).

Amount of BI 6727 that is eliminated in urine from the time point 0 to time point 24 hours (Ae0-24).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=13 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=4 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Amount of BI 6727 That is Eliminated in Urine From the Time Point 0 to Time Point 24 Hours (Ae0-24)	299 Microgram (µg) Geometric Coefficient of Variation 12.4	493 Microgram (µg) Geometric Coefficient of Variation 104	1580 Microgram (µg) Geometric Coefficient of Variation 12.9	1170 Microgram (µg) Geometric Coefficient of Variation 72.9	2120 Microgram (µg) Geometric Coefficient of Variation 14.8	NA Microgram (µg) Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	5960 Microgram (µg) Geometric Coefficient of Variation 56.5	3280 Microgram (µg) Geometric Coefficient of Variation 64.1	3800 Microgram (µg) Geometric Coefficient of Variation 82.2	9790 Microgram (µg) Geometric Coefficient of Variation 84.8	4820 Microgram (µg) Geometric Coefficient of Variation 58.5	6010 Microgram (µg) Geometric Coefficient of Variation 26.7

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 48 hours after the infusion.

Population: Only patients in the treated set (TS) who had non-missing values were included in the analysis. Descriptive statistics for 200mg and 350mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients, respectively. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).

Amount of BI 6727 that is eliminated in urine from the time point 0 to time point 48 hours (Ae0-48).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=13 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=7 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=3 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Amount of BI 6727 That is Eliminated in Urine From the Time Point 0 to Time Point 48 Hours (Ae0-48)	379 Microgram (µg) Geometric Coefficient of Variation 26.1	618 Microgram (µg) Geometric Coefficient of Variation 105	2030 Microgram (µg) Geometric Coefficient of Variation 15.7	1380 Microgram (µg) Geometric Coefficient of Variation 66.5	2630 Microgram (µg) Geometric Coefficient of Variation 14.6	NA Microgram (µg) Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	7810 Microgram (µg) Geometric Coefficient of Variation 58.8	4830 Microgram (µg) Geometric Coefficient of Variation 76.7	5810 Microgram (µg) Geometric Coefficient of Variation 81.6	NA Microgram (µg) Geometric Coefficient of Variation NA Descriptive statistics for the 350 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	6650 Microgram (µg) Geometric Coefficient of Variation 57.4	7930 Microgram (µg) Geometric Coefficient of Variation 26.2

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 24 hours after the infusion.

Population: Only patients in the treated set (TS) who had non-missing values were included in the analysis. Descriptive statistics for 200 mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).

Fraction of BI 6727 (percentage of dose) eliminated in urine from time point 0 to time point 24 hours (Fe0-24).

Outcome measures

Measure	BI 6727 n=3 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=13 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=4 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Fraction of BI 6727 Eliminated in Urine From Time Point 0 to Time Point 24 Hours (Fe0-24)	3.10 Percentage of dose Geometric Coefficient of Variation 12.1	2.38 Percentage of dose Geometric Coefficient of Variation 101	3.65 Percentage of dose Geometric Coefficient of Variation 12.8	1.67 Percentage of dose Geometric Coefficient of Variation 70.8	1.74 Percentage of dose Geometric Coefficient of Variation 13.1	NA Percentage of dose Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	1.99 Percentage of dose Geometric Coefficient of Variation 56.0	1.09 Percentage of dose Geometric Coefficient of Variation 64.1	1.27 Percentage of dose Geometric Coefficient of Variation 82.2	2.80 Percentage of dose Geometric Coefficient of Variation 84.8	1.19 Percentage of dose Geometric Coefficient of Variation 58.4	1.42 Percentage of dose Geometric Coefficient of Variation 35.7

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 48 hours after the infusion.

Population: Only patients in the treated set (TS) who had non-missing values were included in the analysis. Descriptive statistics for 200mg and 350mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients, respectively. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).

Fraction of BI 6727 (percentage of dose) eliminated in urine from time point 0 to time point 48 hours (Fe0-48).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=13 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=7 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=3 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Fraction of BI 6727 Eliminated in Urine From Time Point 0 to Time Point 48 Hours (Fe0-48)	3.75 Percentage of dose Geometric Coefficient of Variation 27.0	2.98 Percentage of dose Geometric Coefficient of Variation 102	4.71 Percentage of dose Geometric Coefficient of Variation 16.2	1.98 Percentage of dose Geometric Coefficient of Variation 64.5	2.16 Percentage of dose Geometric Coefficient of Variation 11.1	NA Percentage of dose Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	2.61 Percentage of dose Geometric Coefficient of Variation 58.3	1.61 Percentage of dose Geometric Coefficient of Variation 76.7	1.94 Percentage of dose Geometric Coefficient of Variation 81.6	NA Percentage of dose Geometric Coefficient of Variation NA Descriptive statistics for the 350 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	1.65 Percentage of dose Geometric Coefficient of Variation 57.2	1.87 Percentage of dose Geometric Coefficient of Variation 35.1

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 24 hours after the infusion.

Population: Only patients in the treated set (TS) who had non-missing values were included in the analysis. Descriptive statistics for 200 mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).

Renal clearance of BI 6727 from the time point 0 to time point 24 hours (CLr,0-24).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=6 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=4 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=4 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Renal Clearance of BI 6727 From the Time Point 0 to Time Point 24 Hours (CLr,0-24)	106 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 11.5	87.6 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 67.8	127 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 11.8	48.4 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 117	56.7 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 11.4	NA Milliliter/minutes (mL/min) Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	42.3 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 69.3	34.5 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 54.9	34.2 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 58.3	66.7 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 89.9	24.5 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 82.9	21.6 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 15.3

SECONDARY outcome

Timeframe: 5 minutes prior to the infusion on day 1, course 1 and up to 48 hours after the infusion.

Population: Only patients in the treated set with non-missing values. For arms with 0 patients analysed: No sufficient data had been collected to determine the terminal half-life T1/2, which is needed to analyse the PK data. Descriptive statistics for 200 and 350 mg group could not be evaluated, since plasma concentrations of BI 6727 was only quantifiable in less than 2/3 of patients, respectively. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated as defined in TSAP.

Renal clearance of BI 6727 from the time point 0 to time point 48 hours (CLr,0-48).

Outcome measures

Measure	BI 6727 n=4 Participants Comprises all dose groups during the dose escalation phase. 12/24/48/75/125/200/300/350/400 and 450 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients). 300 mg 1h2h solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). 300 mg 2h1h solution for infusion of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=2 Participants 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 Participants 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 Participants 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=3 Participants 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=1 Participants 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=11 Participants 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=3 Participants 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=9 Participants 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 Participants 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Renal Clearance of BI 6727 From the Time Point 0 to Time Point 48 Hours (CLr,0-48)	99.8 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 5.89	80.6 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 62.2	118 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 13.5	43.9 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 116	51.6 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 3.77	NA Milliliter/minutes (mL/min) Geometric Coefficient of Variation NA Descriptive statistics for the 200 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP)	41.3 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 71.8	—	—	NA Milliliter/minutes (mL/min) Geometric Coefficient of Variation NA Descriptive statistics for the 350 mg group could not be evaluated, since plasma concentrations was only quantifiable in less than two-thirds of the patients. Descriptive statistics is calculated in case that 2/3 patients of total could be evaluated, as defined in the trial statistical analysis plan (TSAP).	25.8 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 80.9	21.5 Milliliter/minutes (mL/min) Geometric Coefficient of Variation 14.6

Adverse Events

12 mg BI 6727

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

24 mg BI 6727

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

48 mg BI 6727

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

75 mg BI 6727

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

125 mg BI 6727

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

200 mg BI 6727

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

300 mg BI 6727

Serious events: 9 serious events

Other events: 15 other events

Deaths: 6 deaths

300 mg BI 6727 1h2h

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

300 mg BI 6727 2h1h

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

350 mg BI 6727

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

400 mg BI 6727

Serious events: 5 serious events

Other events: 10 other events

Deaths: 2 deaths

450 mg BI 6727

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	12 mg BI 6727 n=4 participants at risk 12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 participants at risk 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 participants at risk 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 participants at risk 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 participants at risk 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 participants at risk 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 participants at risk 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 participants at risk 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 participants at risk 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 2/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	40.0% 2/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Cardiac disorders Angina pectoris	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Eye disorders Vision blurred	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Nausea	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Volvulus	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Vomiting	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Fatigue	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders General physical health deterioration	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 2/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Pyrexia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Appendicitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Fusobacterium infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Lung infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Pneumonia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Septic shock	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Skin infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Viral pericarditis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Troponin increased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Gout	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Malnutrition	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Renal and urinary disorders Urinary retention	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Renal and urinary disorders Urogenital haemorrhage	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Surgical and medical procedures Lymphadenectomy	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Mesenteric haemorrhage	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Pyuria	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Depression	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.

Other adverse events

Measure	12 mg BI 6727 n=4 participants at risk 12 milligram (mg) solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	24 mg BI 6727 n=3 participants at risk 24 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	48 mg BI 6727 n=3 participants at risk 48 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	75 mg BI 6727 n=2 participants at risk 75 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	125 mg BI 6727 n=4 participants at risk 125 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	200 mg BI 6727 n=3 participants at risk 200 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 n=15 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	300 mg BI 6727 1h2h n=8 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	300 mg BI 6727 2h1h n=6 participants at risk 300 mg solution for injection of BI 6727 was administered as intravenous infusion over 2 hour (2h) in course 1 and over 1 hour (1h) in course 2 once every 21 days (as long as there was clinical benefit for the patients). QT extension cohort.	350 mg BI 6727 n=5 participants at risk 350 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	400 mg BI 6727 n=10 participants at risk 400 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).	450 mg BI 6727 n=2 participants at risk 450 mg solution for injection of BI 6727 was administered as intravenous infusion over 60 minutes once every 21 days (as long as there was clinical benefit for the patients).
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	46.7% 7/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	40.0% 2/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	80.0% 8/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 5/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	100.0% 2/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	100.0% 2/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Cardiac disorders Angina pectoris	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Cardiac disorders Cardiac tamponade	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Cardiac disorders Pericardial effusion	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Ear and labyrinth disorders Vertigo	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Eye disorders Photophobia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Eye disorders Vision blurred	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Abdominal discomfort	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Ascites	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Constipation	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	40.0% 4/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 3/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Dry mouth	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Gastric dilatation	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Nausea	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	26.7% 4/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 2/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 4/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	40.0% 2/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	30.0% 3/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Oesophagitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Proctalgia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Stomatitis	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 3/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	30.0% 3/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Toothache	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Vomiting	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	26.7% 4/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Asthenia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Chest pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Fatigue	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	75.0% 3/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	100.0% 3/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	46.7% 7/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	62.5% 5/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	83.3% 5/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 5/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	100.0% 2/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Feeling abnormal	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Feeling cold	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders General physical health deterioration	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Influenza like illness	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Local swelling	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Obstruction	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Oedema	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Oedema peripheral	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 2/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Pyrexia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 3/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Hepatobiliary disorders Hepatic function abnormal	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Hepatobiliary disorders Hepatic pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Anal abscess	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Bronchitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Folliculitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Gastroenteritis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Herpes simplex	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Herpes virus infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Nasopharyngitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Neutropenic infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Rhinitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Urinary tract infection	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Blood magnesium decreased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Blood potassium decreased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Blood urea decreased	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Weight decreased	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Investigations Weight increased	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	75.0% 3/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 2/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	30.0% 3/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Hyperglycaemia	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Dizziness	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 2/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Dysaesthesia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Headache	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Peripheral motor neuropathy	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Somnolence	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Speech disorder	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Anxiety	75.0% 3/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Confusional state	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Hallucination	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Insomnia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Psychiatric disorders Nervousness	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Renal and urinary disorders Dysuria	50.0% 2/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Renal and urinary disorders Haematuria	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 3/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	40.0% 2/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	66.7% 2/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 4/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	30.0% 3/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	30.0% 3/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	13.3% 2/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	20.0% 1/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Haematoma	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Haemorrhage	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Hypertension	25.0% 1/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 2/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Lymphoedema	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	12.5% 1/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Orthostatic hypotension	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	33.3% 1/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Vascular disorders Thrombophlebitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Catheter site pain	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
General disorders Swelling	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Conjunctivitis	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	10.0% 1/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Genital infection fungal	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Influenza	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Infections and infestations Pyuria	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	6.7% 1/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Memory impairment	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Nervous system disorders Restless legs syndrome	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	50.0% 1/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.
Product Issues Thrombosis in device	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/4 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/3 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/15 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/8 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	16.7% 1/6 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/5 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/10 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.	0.00% 0/2 • From first drug administration until last drug administration plus 21 days, up to 835 days. Treated Set (TS): ALL patients who received at least one dose of BI 6727.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

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

Restriction type: OTHER