Trial Outcomes & Findings for Weekly BI 836880 in Patients With Advanced Solid Tumors (NCT NCT02689505)
NCT ID: NCT02689505
Last Updated: 2025-10-01
Results Overview
Determination of the maximum tolerated dose (MTD) in participants with advanced solid tumors. MTD was defined as the highest dose with less than 25% risk of true DLT rate being above 33% in the MTD evaluation period, and could be considered reached if the probability that the true DLT rate was in the target interval (16% to 33%) was sufficiently large during the MTD evaluation period. The MTD evaluation period was defined as 3 weeks after first administration of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period).
Results posted on
2025-10-01
Participant Flow
This was an open-label, non-randomised, uncontrolled, dose-escalating trial in patients with advanced solid tumors.
All subjects who were screened for eligibility to participate in the trial signed informed consent. Subject were assigned to the trial drug if the met all the inclusion and none of the exclusion criteria. Abbreviations: AE = Adverse Event.
Participant milestones
| Measure |
40 mg BI 836880
40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
3
|
11
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
3
|
11
|
3
|
Reasons for withdrawal
| Measure |
40 mg BI 836880
40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
2
|
3
|
9
|
1
|
|
Overall Study
Dose Limiting Toxicity
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Other AE or clinical progression
|
0
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Weekly BI 836880 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
40 mg BI 836880
n=2 Participants
40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
n=5 Participants
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
n=3 Participants
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
n=11 Participants
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
n=3 Participants
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 Years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
56.0 Years
STANDARD_DEVIATION 22.1 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
62.0 Years
STANDARD_DEVIATION 4.6 • n=21 Participants
|
57.2 Years
STANDARD_DEVIATION 12.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period).Population: Dose-finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of trial medication and were evaluable for MTD determination.
Determination of the maximum tolerated dose (MTD) in participants with advanced solid tumors. MTD was defined as the highest dose with less than 25% risk of true DLT rate being above 33% in the MTD evaluation period, and could be considered reached if the probability that the true DLT rate was in the target interval (16% to 33%) was sufficiently large during the MTD evaluation period. The MTD evaluation period was defined as 3 weeks after first administration of treatment.
Outcome measures
| Measure |
Total BI 836880
n=19 Participants
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total BI 836880
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
180 Milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period).Population: Dose finding cohort treated set: All patients enrolled in dose finding and confirmation of MTD cohort of the trial who were documented to have taken at least 1 dose of trial medication and were evaluable for the MTD determination.
The following drug-related adverse events qualified as DLTs: Common Terminology Criteria for Adverse Events (CTCAE) grade 4 neutropenia \>7 days or complicated by infection; grade \>3 febrile neutropenia; grade = 4 thrombocytopenia; grade \> 3 thrombocytopenia with bleeding; grade \> 3 proteinuria \> 3 non haematological toxicity except: Vomiting or diarrhea responding to supporting treatment, fatigue lasting for less than 4 days, transient grade 3 infusion reaction, any laboratory abnormality, which was considered not clinically relevant by the investigator or resolved spontaneously or could be resolved with appropriate treatment. Hypertension: increase of diastolic blood pressure (BP) by 15 mmHg, which could not be controlled by hypertensive medication and requires a dose reduction of BI 836880 for further treatment course. All related AE leading to an interruption of BI 836880 for more than 14 days until recovery to baseline.
Outcome measures
| Measure |
Total BI 836880
n=2 Participants
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
n=5 Participants
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
n=3 Participants
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
n=6 Participants
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
n=3 Participants
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total BI 836880
n=19 Participants
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.Population: Treated Set: The treated set includes all participants enrolled in the Trial who were documented to have taken at least one dose of study medication.
Number of Participants with drug-related adverse Events (AEs) leading to dose reduction or discontinuation during the treatment period.
Outcome measures
| Measure |
Total BI 836880
n=2 Participants
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
n=5 Participants
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
n=3 Participants
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
n=11 Participants
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
n=3 Participants
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total BI 836880
n=24 Participants
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events (AEs) Leading to Dose Reduction or Discontinuation During the Treatment Period
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
Adverse Events
40 mg BI 836880
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
120 mg BI 836880
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
150 mg BI 836880
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
180 mg BI 836880
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
240 mg BI 836880
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Total BI 836880
Serious events: 12 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40 mg BI 836880
n=2 participants at risk
40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
n=5 participants at risk
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
n=3 participants at risk
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
n=11 participants at risk
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
n=3 participants at risk
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total BI 836880
n=24 participants at risk
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
Other adverse events
| Measure |
40 mg BI 836880
n=2 participants at risk
40 milligram (mg) solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
120 mg BI 836880
n=5 participants at risk
120 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
150 mg BI 836880
n=3 participants at risk
150 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
180 mg BI 836880
n=11 participants at risk
180 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
240 mg BI 836880
n=3 participants at risk
240 mg solution of BI 836880 was administered as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
Total BI 836880
n=24 participants at risk
Participants were administered 40/ 120/ 150 / 180 /240 milligram (mg) solution of BI 836880 as once weekly intravenous infusion in 3 weeks treatment cycles. Participants continued treatment until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
12.5%
3/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
66.7%
2/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.8%
5/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
25.0%
6/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
27.3%
3/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
25.0%
6/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
25.0%
6/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
66.7%
2/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
16.7%
4/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.8%
5/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Asthenia
|
100.0%
2/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
80.0%
4/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
63.6%
7/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
62.5%
15/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Chest pain
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Localised oedema
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Malaise
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
12.5%
3/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
General disorders
Xerosis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
27.3%
3/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.8%
5/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
27.3%
3/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.8%
5/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
80.0%
4/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
66.7%
2/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
37.5%
9/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
66.7%
2/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
16.7%
4/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
16.7%
4/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
16.7%
4/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
27.3%
3/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
16.7%
4/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
27.3%
3/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.8%
5/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
33.3%
1/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
40.0%
2/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
9.1%
1/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
12.5%
3/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
18.2%
2/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
8.3%
2/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/2 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
20.0%
1/5 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/11 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
0.00%
0/3 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
4.2%
1/24 • From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.
Treated set: All participants who were treated with at least one single dose of BI 836880.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review Prior to any Submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI´s intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER