Trial Outcomes & Findings for BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL) (NCT NCT01296932)
NCT ID: NCT01296932
Last Updated: 2020-08-20
Results Overview
Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
14 days after first administration of BI836826 (MTD evaluation period)
Results posted on
2020-08-20
Participant Flow
This was a Phase-1,single arm,open-label,dose escalation trial, patients with advanced chronic lymphocytic leukemia. While the first part of the trial was still in progress, recruitment was ended by the sponsor before the maximum tolerated dose(MTD) or Optimal Biological Dose(OBD) was reached.
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 836826 1 Milligram
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
6
|
3
|
3
|
6
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
6
|
3
|
3
|
6
|
2
|
4
|
Reasons for withdrawal
| Measure |
BI 836826 1 Milligram
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Dose limiting toxicity
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Progressive disease
|
2
|
0
|
1
|
1
|
2
|
3
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Investigator decision
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
No clinical benefit anymore
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
IV problems, administration not possible
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
per protocol
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Low benefit and too many side effects
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
No adequate treatment response
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Dosage already reduced, AE still present
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
Baseline characteristics by cohort
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
21 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
16 Participants
n=64 Participants
|
|
Age, Continuous
|
67.7 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
74.3 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
63.3 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
58.7 Years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
63.3 Years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
61.0 Years
STANDARD_DEVIATION 17.0 • n=10 Participants
|
73.3 Years
STANDARD_DEVIATION 5.4 • n=115 Participants
|
70.7 Years
STANDARD_DEVIATION 11.4 • n=6 Participants
|
69.5 Years
STANDARD_DEVIATION 6.5 • n=6 Participants
|
66.5 Years
STANDARD_DEVIATION 10.2 • n=64 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
11 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
26 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 14 days after first administration of BI836826 (MTD evaluation period)Population: The maximum tolerated dose (MTD) evaluation set: This includes all patients who were documented to have received at least one dose of trial medication and were not replaced for the MTD evaluation.
Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=5 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=3 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs)
Total with dose limiting toxicities adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 days after first administration of BI836826 (MTD evaluation period)Population: The trial was discontinued prematurely due to lack of recruitment before the MTD based on the frequency of patients with DLTs in the first treatment cycle was reached.
The maximum tolerated dose (MTD) was defined as the highest dose of BI 836826 studied for which the incidence of DLT was no more than 17% (i.e. 1 out of 6 patients) during the first treatment cycle. For those patients who received more than 1 cycle of BI 836826, all AEs corresponding to the DLT were considered for the purpose of confirming the MTD and for the selection of the recommended dose for treatment of the expansion cohort and for further development. All DLTs, occurring during the first or repeated treatment cycle were reported as significant AEs. As it was not possible to recruit a sufficient number of patients whilst the first part of the trial was still in progress, the recruitment was ended by the sponsor before the MTD or optimal biological dose (OBD) was reached.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 daysPopulation: All patients who received at least one application of the drug BI 836826, had a baseline and at least one post-baseline assessment of the number of lymphocytes in the peripheral blood.
In most patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), malignant B-cells represent the majority of lymphocytes in the peripheral blood. Reduction of CLL-cells was assessed in the peripheral blood by absolute lymphocyte count, and flow cytometry. The number of lymphocytes in the peripheral blood was analysed in terms of the best percentage change from baseline until start of subsequent CLL therapy or progressive disease (PD).
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=5 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood
|
-11.39 Percentage of change (%)
Standard Deviation 31.39
|
-21.20 Percentage of change (%)
Standard Deviation 10.08
|
-48.21 Percentage of change (%)
Standard Deviation 57.39
|
-48.15 Percentage of change (%)
Standard Deviation 34.01
|
-49.35 Percentage of change (%)
Standard Deviation 31.44
|
-81.81 Percentage of change (%)
Standard Deviation 11.03
|
-79.22 Percentage of change (%)
Standard Deviation 39.94
|
-93.40 Percentage of change (%)
Standard Deviation 9.76
|
-47.14 Percentage of change (%)
Standard Deviation 103.29
|
SECONDARY outcome
Timeframe: ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 daysPopulation: Treated Set (TS): All patients who received at least one application of the drug BI 836826.
In patients with haemoglobin counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved haemoglobin count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments
NO
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments
YES
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 daysPopulation: TS
In patients with platelet counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved platelet count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments
NO
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments
YES
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 daysPopulation: TS
In patients with neutrophil count below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved neutrophil count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments
NO
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments
YES
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days.Population: TS
Response was assessed according to the IWCLL (International Workshop on Chronic Lymphocytic Leukemia) guidelines based on laboratory data from the peripheral blood and clinical examination by the investigator after each cycle prior to administration of the next dose of BI 836826, at the end of the treatment (EOT) visit, and at all Follow-up Visits. Best overall response will be analysed descriptively. Frequency distributions will be used to examine this endpoint.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Complete remission
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Complete remission with incomplete marrow recovery
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Partial remission
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Stable disease
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria
Progressive disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 26Oct2016, Up to 1809 days.Population: TS
Progression-free survival (PFS) was defined as the time from the first administration of BI 836826 until disease progression or death, whichever occurred first. Disease progression= At least one of the following: * 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L * Progression of lymphadenopathy * 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly * 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly * 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia * Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
57.0 Days
Interval 15.0 to 316.0
|
86.0 Days
Interval 59.0 to 141.0
|
133.5 Days
Interval 79.0 to 281.0
|
81.0 Days
Interval 29.0 to 134.0
|
85.0 Days
Interval 16.0 to 106.0
|
114.0 Days
Interval 44.0 to 133.0
|
196.5 Days
Interval 98.0 to 247.0
|
113.0 Days
Interval 106.0 to 799.0
|
68.0 Days
Interval 51.0 to 74.0
|
SECONDARY outcome
Timeframe: Data collected up to cut-off date 26Oct2016, Up to 1809 days.Population: TS
Failure-free survival (FFS) was defined as the time from the first administration of BI 836826 until disease progression or death, or start of next Chronic Lymphocytic Leukemia (CLL) therapy, whichever occurred first. Disease progression= At least one of the following: * 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L * Progression of lymphadenopathy * 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly * 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly * 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia * Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.
Outcome measures
| Measure |
BI 836826 1 Milligram
n=3 Participants
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 Participants
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 Participants
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 Participants
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 Participants
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 Participants
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 Participants
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 Participants
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 Participants
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Failure-free Survival
|
57.0 Days
Interval 29.0 to 316.0
|
106.0 Days
Interval 59.0 to 141.0
|
152.5 Days
Interval 85.0 to 281.0
|
81.0 Days
Interval 29.0 to 134.0
|
85.0 Days
Interval 25.0 to 106.0
|
114.0 Days
Interval 54.0 to 133.0
|
196.5 Days
Interval 127.0 to 247.0
|
149.0 Days
Interval 120.0 to 799.0
|
100.0 Days
Interval 68.0 to 141.5
|
Adverse Events
BI 836826 1 Milligram
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 836826 3 Milligram
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 836826 9 Milligram
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 836826 25 Milligram
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 836826 50 Milligram
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 836826 100 Milligram
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 836826 200 Milligram
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 836826 400 Milligram
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 836826 800 Milligram
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 836826 1 Milligram
n=3 participants at risk
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 participants at risk
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 participants at risk
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 participants at risk
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 participants at risk
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 participants at risk
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 participants at risk
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 participants at risk
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 participants at risk
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
Other adverse events
| Measure |
BI 836826 1 Milligram
n=3 participants at risk
Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 3 Milligram
n=3 participants at risk
Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle
|
BI 836826 9 Milligram
n=6 participants at risk
Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 25 Milligram
n=6 participants at risk
Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 50 Milligram
n=3 participants at risk
Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 100 Milligram
n=3 participants at risk
Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 200 Milligram
n=6 participants at risk
Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 400 Milligram
n=3 participants at risk
Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
BI 836826 800 Milligram
n=4 participants at risk
Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Axillary pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
83.3%
5/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
100.0%
3/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
100.0%
4/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Vitamin B12 increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
T-lymphocyte count decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
Weight increased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Investigations
pH urine decreased
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
100.0%
3/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
100.0%
3/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
75.0%
3/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
75.0%
3/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Mitral valve calcification
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Ear and labyrinth disorders
Middle ear effusion
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Gastrointestinal disorders
Submaxillary gland enlargement
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Chills
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
75.0%
3/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Discomfort
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Extravasation
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Facial pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Feeling hot
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Hypothermia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Malaise
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Oedema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Puncture site pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
4/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Ear infection
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Ageusia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Product Issues
Thrombosis in device
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Reproductive system and breast disorders
Uterine polyp
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
66.7%
2/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
2/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
2/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
50.0%
3/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
25.0%
1/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
33.3%
1/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
16.7%
1/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/6 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/3 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
0.00%
0/4 • From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks
The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)
|
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