Trial Outcomes & Findings for BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (NCT NCT01403948)

NCT ID: NCT01403948

Last Updated: 2020-08-11

Results Overview

The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

From the first administration of trial medication to 7 days after the second administration, upto 36 days

Results posted on

2020-08-11

Participant Flow

This was an open-label trial with a dose-escalation phase according to a modified 3+3 design.

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure
BI 836826 1 mg iv (Caucasian Patients)
BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50mg iv (Korean Patients)
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Korean Patients)
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Overall Study
STARTED
1
4
3
4
6
7
6
4
6
7
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
1
4
3
4
6
7
6
4
6
7

Reasons for withdrawal

Reasons for withdrawal
Measure
BI 836826 1 mg iv (Caucasian Patients)
BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50mg iv (Korean Patients)
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Korean Patients)
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Overall Study
Progressive disease
0
2
2
4
2
6
2
4
5
5
Overall Study
Other Adverse Event (Other than DLT)
0
0
0
0
2
0
2
0
1
0
Overall Study
Lost to Follow-up
0
0
0
0
0
0
0
0
0
1
Overall Study
Refused cont. medication
0
0
0
0
1
0
0
0
0
1
Overall Study
other than above
1
2
1
0
1
1
2
0
0
0

Baseline Characteristics

BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BI 836826 1 mg iv (Caucasian Patients)
n=1 Participants
BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50mg iv (Korean Patients)
n=7 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Korean Patients)
n=4 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Total
n=48 Participants
Total of all reporting groups
Age, Continuous
75.0 Years
n=5 Participants
75.0 Years
n=7 Participants
61.0 Years
n=5 Participants
69.5 Years
n=4 Participants
74.5 Years
n=21 Participants
57.0 Years
n=8 Participants
69.0 Years
n=8 Participants
70.0 Years
n=24 Participants
66.0 Years
n=42 Participants
68.0 Years
n=42 Participants
68.5 Years
n=42 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
4 Participants
n=8 Participants
2 Participants
n=8 Participants
3 Participants
n=24 Participants
1 Participants
n=42 Participants
3 Participants
n=42 Participants
18 Participants
n=42 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
4 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
4 Participants
n=21 Participants
3 Participants
n=8 Participants
4 Participants
n=8 Participants
1 Participants
n=24 Participants
5 Participants
n=42 Participants
4 Participants
n=42 Participants
30 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 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
7 Participants
n=8 Participants
0 Participants
n=8 Participants
4 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
11 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 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=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
0 Participants
n=8 Participants
6 Participants
n=8 Participants
0 Participants
n=24 Participants
4 Participants
n=42 Participants
5 Participants
n=42 Participants
33 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
2 Participants
n=42 Participants
4 Participants
n=42 Participants

PRIMARY outcome

Timeframe: From the first administration of trial medication to 7 days after the second administration, upto 36 days

Population: Treated Set

The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.

Outcome measures

Outcome measures
Measure
BI 836826
n=37 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
100 Milligram (mg)

PRIMARY outcome

Timeframe: From the first administration of trial medication to 7 days after the second administration, up to 36 days

Population: Treated Set

Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
1 Participants

SECONDARY outcome

Timeframe: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

Population: Treated set

Tumour size reduction (lymph nodes, spleen, \& liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD). Negative value represents decrease in tumour size, \& positive value represents an increase in size. The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan. Spleen \& liver were to be described if considered enlarged at baseline by physical examination or CT scan. If nodules present in spleen \&/or liver, was to be measured in 2 perpendicular dimensions. Median, 25th \& 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Tumour Size Reduction
indicator lesions
-44.74 Percentage
Standard Deviation NA
Only one patient has been analysed thus SD is not calculable
118.42 Percentage
Standard Deviation 183.49
-0.11 Percentage
Standard Deviation 61.72
67.26 Percentage
Standard Deviation 61.78
-3.72 Percentage
Standard Deviation 10.19
28.80 Percentage
Standard Deviation 78.03
-9.44 Percentage
Standard Deviation 34.49
110.88 Percentage
Standard Deviation 41.82
60.13 Percentage
Standard Deviation 29.68
1.90 Percentage
Standard Deviation NA
Only one patient has been analysed thus SD is not calculable
Tumour Size Reduction
liver nodules
33.16 Percentage
Standard Deviation NA
Only one patient has been analysed thus SD is not calculable

SECONDARY outcome

Timeframe: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)

Population: Treated set

Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.: 1. Complete remission (CR) 2. Complete remission unconfirmed (CRu) 3. Partial remission (PR) 4. Stable disease (SD) 5. progressive disease (PD)

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Best Overall Response Based on All Assessment
Complete remission
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on All Assessment
Complete remission unconfirmed
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on All Assessment
Partial remission
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
3 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on All Assessment
Stable disease
1 Participants
3 Participants
2 Participants
2 Participants
3 Participants
3 Participants
2 Participants
2 Participants
0 Participants
2 Participants
Best Overall Response Based on All Assessment
Progressive disease
0 Participants
0 Participants
1 Participants
2 Participants
1 Participants
3 Participants
0 Participants
2 Participants
5 Participants
4 Participants
Best Overall Response Based on All Assessment
Missing
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.

Population: Treated set

Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.: 1. Complete remission 2. Complete remission unconfirmed 3. Partial remission 4. Stable disease: 5. progressive disease

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Best Overall Response Based on Imaging Data
Missing
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants
Best Overall Response Based on Imaging Data
Complete remission
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on Imaging Data
Complete remission unconfirmed
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on Imaging Data
Partial remission
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
Best Overall Response Based on Imaging Data
Stable disease
1 Participants
1 Participants
1 Participants
0 Participants
3 Participants
1 Participants
1 Participants
0 Participants
0 Participants
2 Participants
Best Overall Response Based on Imaging Data
Progressive disease
0 Participants
2 Participants
2 Participants
4 Participants
2 Participants
5 Participants
2 Participants
4 Participants
5 Participants
4 Participants

SECONDARY outcome

Timeframe: from first treatment until disease progression or death from any cause, up to 12 months.

Population: Treated set

PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion \>1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of \<1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node \>1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Progression Free Survival (PFS)
352.00 days
Interval 352.0 to 352.0
87.00 days
Interval 47.0 to
Not calculable due to insufficient number of patients with event
81.00 days
Interval 17.0 to
Not calculable due to insufficient number of patients with event
22.00 days
Interval 12.0 to 36.0
262.00 days
Interval 85.0 to 262.0
27.50 days
Interval 24.0 to 38.0
200.00 days
Interval 62.0 to 218.0
51.50 days
Interval 39.5 to 88.5
34.00 days
Interval 22.0 to 44.0
38.00 days
Interval 19.0 to
Not calculable due to insufficient number of patients with event

SECONDARY outcome

Timeframe: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.

Population: Treated set

FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion \>1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of \<1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node \>1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort.

Outcome measures

Outcome measures
Measure
BI 836826
n=1 Participants
Caucasian patients were treated in the dose-escalation phase with BI 836826 as an intravenous infusion until the patient met criteria for stopping study medication during the MTD evaluation period. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 Participants
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=4 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 Participants
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 Participants
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Failure Free Survival (FFS)
352.00 days
Interval 352.0 to 352.0
87.00 days
Interval 47.0 to 116.0
81.00 days
Interval 17.0 to 199.0
22.00 days
Interval 12.0 to 36.0
85.00 days
Interval 18.0 to 262.0
25.00 days
Interval 23.0 to 38.0
200.00 days
Interval 62.0 to 218.0
51.50 days
Interval 39.5 to 88.5
34.00 days
Interval 22.0 to 44.0
36.00 days
Interval 19.0 to 52.0

Adverse Events

BI 836826 1 mg iv (Caucasian Patients)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

BI 836826 3 mg iv (Caucasian Patients)

Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths

BI 836826 9 mg iv (Caucasian Patients)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths

BI 836826 25 mg iv (Caucasian Patients)

Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths

BI 836826 50 mg iv (Caucasian Patients)

Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths

BI 836826 50mg iv (Korean Patients)

Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths

BI 836826 100 mg iv (Caucasian Patients)

Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths

BI 836826 100 mg iv (Korean Patients)

Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths

BI 836826 150 mg iv (Caucasian Patients)

Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths

BI 836826 200 mg iv (Caucasian Patients)

Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
BI 836826 1 mg iv (Caucasian Patients)
n=1 participants at risk
BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 participants at risk
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 participants at risk
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 participants at risk
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50mg iv (Korean Patients)
n=7 participants at risk
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Korean Patients)
n=4 participants at risk
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 participants at risk
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Chylothorax
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Anaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Atrial fibrillation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Atrial tachycardia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Tachycardia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Gastritis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Stomatitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Asthenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
General physical health deterioration
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Bacteraemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Bronchitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Device related infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Escherichia bacteraemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Herpes zoster
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Oral herpes
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Otitis media
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Pneumonia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Pulmonary mycosis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Pyelonephritis acute
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Sepsis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Septic shock
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Urinary tract infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood lactate dehydrogenase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
C-reactive protein increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Dehydration
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal neoplasm benign
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Headache
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Neurological symptom
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Confusional state
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Acute kidney injury
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Ureteric obstruction
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Superior vena cava syndrome
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days

Other adverse events

Other adverse events
Measure
BI 836826 1 mg iv (Caucasian Patients)
n=1 participants at risk
BI 836826 1 milligram (mg) was administered as an intravenous (iv) infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 3 mg iv (Caucasian Patients)
n=4 participants at risk
BI 836826 3 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 9 mg iv (Caucasian Patients)
n=3 participants at risk
BI 836826 9 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 25 mg iv (Caucasian Patients)
n=4 participants at risk
BI 836826 25 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 50mg iv (Korean Patients)
n=7 participants at risk
BI 836826 50 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 100 mg iv (Korean Patients)
n=4 participants at risk
BI 836826 100 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in korean patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 150 mg iv (Caucasian Patients)
n=6 participants at risk
BI 836826 150 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
BI 836826 200 mg iv (Caucasian Patients)
n=7 participants at risk
BI 836826 200 mg was administered as an intravenous infusion anytime in day (preferably morning hours) in caucasian patients with relapsed or refractory non-hodgkin lymphoma of B cell origin. Each course was to comprise 4 administrations at weekly intervals, followed by 27 days of observation after last administration. The duration of the 2 first courses was 7 weeks each and the duration of the 3rd course was 12 weeks. The maximum duration of the treatment and observation/rest periods was 26 weeks.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
3/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Anaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
75.0%
3/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
3/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Leukopenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
3/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
83.3%
5/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
66.7%
4/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
3/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
83.3%
5/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
4/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
100.0%
3/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Aortic valve calcification
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Atrial fibrillation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Bradycardia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Coronary artery stenosis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Sinus tachycardia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Cardiac disorders
Tachycardia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Ear and labyrinth disorders
Ear pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Ear and labyrinth disorders
Middle ear effusion
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Ear and labyrinth disorders
Tinnitus
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Ear and labyrinth disorders
Vertigo
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Endocrine disorders
Hyperthyroidism
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Eye disorders
Dry eye
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Abdominal pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Anal fissure
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Ascites
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Colitis microscopic
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Constipation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
66.7%
2/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Diarrhoea
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Dry mouth
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Dyspepsia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Dysphagia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Flatulence
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Gingival bleeding
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Ileus
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Inguinal hernia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Nausea
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Oesophagitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Oral disorder
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Oral pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Proctalgia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Stomatitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Gastrointestinal disorders
Vomiting
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Asthenia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Chest discomfort
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Chest pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Chills
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
71.4%
5/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Drug intolerance
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Face oedema
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Facial pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Fatigue
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Feeling hot
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
General physical health deterioration
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Generalised oedema
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Mucosal inflammation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Oedema
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Oedema mucosal
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Oedema peripheral
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Pain
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Peripheral swelling
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Pyrexia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
57.1%
4/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
General disorders
Swelling
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Immune system disorders
Hypogammaglobulinaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Angular cheilitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Bacteraemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Bronchitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Candida infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Clostridium difficile colitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Cytomegalovirus infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Diverticulitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Enterococcal infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Enterocolitis infectious
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Erysipelas
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Febrile infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Gastrointestinal infection
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Herpes virus infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Herpes zoster
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Influenza
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Laryngitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Oesophageal candidiasis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Oral candidiasis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Oral infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Pneumonia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Septic shock
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Sinusitis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Upper respiratory tract infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
75.0%
3/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Urinary tract infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Infections and infestations
Vaginal infection
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Drug administration error
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
3/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
85.7%
6/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Limb injury
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Post procedural fever
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Injury, poisoning and procedural complications
Wound
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Alanine aminotransferase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Aspartate aminotransferase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Bacterial test positive
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood alkaline phosphatase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood bilirubin increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood calcium decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood creatinine increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Blood lactate dehydrogenase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Body temperature increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
C-reactive protein increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
CD4 lymphocytes decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Cytomegalovirus test positive
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Gamma-glutamyltransferase increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Lymphocyte count decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Neutrophil count decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
42.9%
3/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Platelet count decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Prostatic specific antigen increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Troponin T increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Weight decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
Weight increased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Investigations
White blood cell count decreased
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Fluid imbalance
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
66.7%
4/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Arthralgia
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Myalgia
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Musculoskeletal and connective tissue disorders
Tendon disorder
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Dizziness
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Dysaesthesia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Dysgeusia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Headache
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Hypoaesthesia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Neuropathy peripheral
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Paraesthesia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Polyneuropathy
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Post herpetic neuralgia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Presyncope
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Sciatica
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Syncope
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Nervous system disorders
Tremor
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Delirium
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Insomnia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Listless
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Sleep disorder
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Stress
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Psychiatric disorders
Substance-induced psychotic disorder
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Acute kidney injury
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Azotaemia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Calculus bladder
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Dysuria
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Hydronephrosis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Incontinence
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Polyuria
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Renal failure
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Renal and urinary disorders
Urinary incontinence
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Reproductive system and breast disorders
Pelvic pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Reproductive system and breast disorders
Testicular swelling
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
66.7%
2/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
2/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dry throat
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
50.0%
2/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Respiratory, thoracic and mediastinal disorders
Throat tightness
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Eczema
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
33.3%
1/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Pruritus
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Rash
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Circulatory collapse
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Hot flush
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Hypertension
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Hypertensive crisis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Hypotension
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
28.6%
2/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
16.7%
1/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Peripheral arterial occlusive disease
100.0%
1/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Thrombosis
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
14.3%
1/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
Vascular disorders
Varicose vein
0.00%
0/1 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
25.0%
1/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/3 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/4 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/6 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days
0.00%
0/7 • From the first drug (BI 836826) administration to 8 weeks after the last administration, ie up to 134 days

Additional Information

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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