Trial Outcomes & Findings for A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD) (NCT NCT03861234)
NCT ID: NCT03861234
Last Updated: 2024-11-20
Results Overview
Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
Results posted on
2024-11-20
Participant Flow
A non-randomised, uncontrolled, open label trial consisting of a single rising dose (SRD) part followed by a multiple rising dose (MRD) part. The SRD part and MRD cohort 1 included patients with treatment-resistant wet age-related macular degeneration (wAMD). Patients with treatment-naïve wAMD were included in MRD cohort 2 and patients within 3 years of initial wAMD were included in MRD cohort 3.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
0.06 mg BI 836880 - SRD Part
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - Cohort 1 MRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836680 - Cohort 2 MRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.
|
2 mg BI 836680 - Cohort 3 MRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
11
|
4
|
13
|
|
Overall Study
Treated
|
3
|
3
|
3
|
3
|
3
|
10
|
4
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
8
|
1
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
0.06 mg BI 836880 - SRD Part
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - Cohort 1 MRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836680 - Cohort 2 MRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.
|
2 mg BI 836680 - Cohort 3 MRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study medication discontinued due to safety notification
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
As per sponsor decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
IMP on hold as per sponsor instructions
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
Baseline characteristics by cohort
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 Participants
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - Cohort 1 MRD Part
n=10 Participants
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836680 - Cohort 2 MRD Part
n=4 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.
|
2 mg BI 836680 - Cohort 3 MRD Part
n=13 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
81.7 Years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
76.7 Years
STANDARD_DEVIATION 4.2 • n=107 Participants
|
75.3 Years
STANDARD_DEVIATION 1.5 • n=206 Participants
|
75.7 Years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
70.7 Years
STANDARD_DEVIATION 1.2 • n=31 Participants
|
77.0 Years
STANDARD_DEVIATION 4.8 • n=30 Participants
|
69.3 Years
STANDARD_DEVIATION 13.0 • n=3 Participants
|
77.0 Years
STANDARD_DEVIATION 6.3 • n=6 Participants
|
75.9 Years
STANDARD_DEVIATION 6.4 • n=114 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
17 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
25 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
42 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
42 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.Population: Treated Set: All patients who were treated with at least on dose of BI 836880. SRD-part.
Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 Participants
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.Population: Treated Set: All patients who were treated with at least on dose of BI 836880. MRD-part.
Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=10 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=4 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=13 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
MRD-part: Number of Participants With Drug Related Adverse Events (AEs)
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836680. SRD-part.
Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 Participants
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
SRD-part: Number of Participants With Drug Related Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. SRD-part.
Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 Participants
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 Participants
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At baseline and at week 12.Population: Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.
Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=10 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=4 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=12 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12
|
-7.7554 Percentage change
Standard Deviation 18.9936
|
-26.5552 Percentage change
Standard Deviation 12.1400
|
-0.1372 Percentage change
Standard Deviation 20.1706
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and at Week 12.Population: Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.
Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment.
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=10 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=4 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=13 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12
|
-1.2 Letters
Standard Deviation 6.4
|
1.8 Letters
Standard Deviation 2.5
|
-4.7 Letters
Standard Deviation 22.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From last drug administration at Week 8 until End of Trial, up to 16 weeks.Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.
Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator: * Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR * Decrease in BCVA of \>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR * Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored.
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=10 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=4 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=13 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit
|
8.0 Weeks
Interval 4.6 to 16.1
|
NA Weeks
Median and confidence interval could not be calculated, as there was no event ("recurrence").
|
NA Weeks
Interval 8.1 to
Median and upper confidence interval could not be calculated, as all patients either censored or had events before the probability of recurrence reached to 50%.
|
—
|
—
|
SECONDARY outcome
Timeframe: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.
Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.
Outcome measures
| Measure |
0.06 mg BI 836880 - SRD Part
n=10 Participants
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=4 Participants
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=13 Participants
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
|---|---|---|---|---|---|
|
MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
|
5 Participants
|
1 Participants
|
9 Participants
|
—
|
—
|
Adverse Events
0.06 mg BI 836880 - SRD Part
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
0.18 mg BI 836880 - SRD Part
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.5 mg BI 836880 - SRD Part
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg BI 836880 - SRD Part
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2 mg BI 836880 - SRD Part
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 mg BI 836880 - Cohort 1 MRD Part
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
2 mg BI 836680 - Cohort 2 MRD Part
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2 mg BI 836680 - Cohort 3 MRD Part
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 participants at risk
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 participants at risk
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 participants at risk
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 participants at risk
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - Cohort 1 MRD Part
n=10 participants at risk
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836680 - Cohort 2 MRD Part
n=4 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.
|
2 mg BI 836680 - Cohort 3 MRD Part
n=13 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
33.3%
1/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
15.4%
2/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Retinal occlusive vasculitis
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Depressed fracture
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
Other adverse events
| Measure |
0.06 mg BI 836880 - SRD Part
n=3 participants at risk
0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.18 mg BI 836880 - SRD Part
n=3 participants at risk
0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
0.5 mg BI 836880 - SRD Part
n=3 participants at risk
0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - SRD Part
n=3 participants at risk
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836880 - SRD Part
n=3 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
1 mg BI 836880 - Cohort 1 MRD Part
n=10 participants at risk
1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD).
|
2 mg BI 836680 - Cohort 2 MRD Part
n=4 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD.
|
2 mg BI 836680 - Cohort 3 MRD Part
n=13 participants at risk
2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Anterior chamber cell
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
33.3%
1/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
33.3%
1/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Subretinal fluid
|
33.3%
1/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
15.4%
2/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
20.0%
2/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
15.4%
2/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Vitreal cells
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
15.4%
2/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
66.7%
2/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
15.4%
2/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
General disorders
Malaise
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
20.0%
2/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
20.0%
2/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood folate decreased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Heart rate irregular
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Oxygen saturation abnormal
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Investigations
Tear break up time decreased
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
25.0%
1/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
7.7%
1/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/3 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
10.0%
1/10 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/4 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
0.00%
0/13 • SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER