Trial Outcomes & Findings for A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread (NCT NCT04147247)
NCT ID: NCT04147247
Last Updated: 2023-11-29
Results Overview
The MTD/OBD of BI 905681. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, in the first cycle of treatment (3 weeks). The MTD is defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
The first cycle of treatment, up to 21 days.
Results posted on
2023-11-29
Participant Flow
This was a Phase I, open-label, non-randomised dose-escalation study of BI 905681 administered intravenously as a single agent in patients with advanced solid tumors.
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 |
1.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
2.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
4
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
4
|
5
|
Reasons for withdrawal
| Measure |
1.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
2.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
3
|
3
|
4
|
4
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Clinical Disease Progression
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
Baseline characteristics by cohort
| Measure |
1.0 Milligram/Kilogram BI 905681
n=3 Participants
Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
2.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
62.0 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
60.9 years
STANDARD_DEVIATION 11.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: The first cycle of treatment, up to 21 days.Population: MTD Evaluation Set (MTDS): includes all patients who received at least one infusion of BI 905681 and who were not replaced for the MTD determination.
The MTD/OBD of BI 905681. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, in the first cycle of treatment (3 weeks). The MTD is defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Outcome measures
| Measure |
BI 905681
n=18 Participants
Comprises all dose cohorts during the dose escalation phase. Subjects received an intravenous infusion of BI 905681 on day 1 of each cycle (1 cycle = 21 days).
|
2.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD)/Optimal Biological Dose (OBD) of BI 905681
|
NA milligram/kilogram
The MTD could not be determined due to the prematurely discontinuation of the trial. The trial was completed according to protocol but stopped early due to a lack of response.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first administration of study till the last administration of study drug +42 days, up to 126 days.Population: Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
Number of patients experiencing adverse events (AEs) during the entire treatment period.
Outcome measures
| Measure |
BI 905681
n=3 Participants
Comprises all dose cohorts during the dose escalation phase. Subjects received an intravenous infusion of BI 905681 on day 1 of each cycle (1 cycle = 21 days).
|
2.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
|
2 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.Population: Pharmacokinetics Analysis Set (PKS): All patients who received at least one infusion of BI 905681 and who provide at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK. two subjects were excluded, one subject due to having a prolonged infusion (1mg/kg group) and one subject (8.5 mg/kg group) was not able to receive the full dose due to safety reasons.
Cmax: maximum measured concentration of BI 905681 in serum after first infusion.
Outcome measures
| Measure |
BI 905681
n=2 Participants
Comprises all dose cohorts during the dose escalation phase. Subjects received an intravenous infusion of BI 905681 on day 1 of each cycle (1 cycle = 21 days).
|
2.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Measured Concentration of BI 905681 in Serum After First Infusion
|
NA microgram/milliliter
Geometric Coefficient of Variation NA
not calculable with two subjects.
|
49.6 microgram/milliliter
Geometric Coefficient of Variation 19.7
|
157 microgram/milliliter
Geometric Coefficient of Variation 18.0
|
185 microgram/milliliter
Geometric Coefficient of Variation 23.1
|
201 microgram/milliliter
Geometric Coefficient of Variation 21.4
|
SECONDARY outcome
Timeframe: 5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.Population: Pharmacokinetics Analysis Set (PKS): All patients who received at least one infusion of BI 905681 and who provide at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK. one subject (8.5 mg/kg group) was excluded due to not being able to receive the full dose for safety reasons.
AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz).
Outcome measures
| Measure |
BI 905681
n=3 Participants
Comprises all dose cohorts during the dose escalation phase. Subjects received an intravenous infusion of BI 905681 on day 1 of each cycle (1 cycle = 21 days).
|
2.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 Participants
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=4 Participants
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
AUC0-tz: Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (tz)
|
4260 hour*microgram/milliliter
Geometric Coefficient of Variation 27.8
|
7640 hour*microgram/milliliter
Geometric Coefficient of Variation 10.6
|
18200 hour*microgram/milliliter
Geometric Coefficient of Variation 53.2
|
30000 hour*microgram/milliliter
Geometric Coefficient of Variation 23.8
|
18900 hour*microgram/milliliter
Geometric Coefficient of Variation 217
|
Adverse Events
1.0 Milligram/Kilogram BI 905681
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
2.5 Milligram/Kilogram BI 905681
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
5.0 Milligram/Kilogram BI 905681
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
7.0 Milligram/Kilogram BI 905681
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
8.5 Milligram/Kilogram BI 905681
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.0 Milligram/Kilogram BI 905681
n=3 participants at risk
Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
2.5 Milligram/Kilogram BI 905681
n=4 participants at risk
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 participants at risk
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 participants at risk
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=5 participants at risk
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
33.3%
1/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
Other adverse events
| Measure |
1.0 Milligram/Kilogram BI 905681
n=3 participants at risk
Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
2.5 Milligram/Kilogram BI 905681
n=4 participants at risk
Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
5.0 Milligram/Kilogram BI 905681
n=5 participants at risk
Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
7.0 Milligram/Kilogram BI 905681
n=4 participants at risk
Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
8.5 Milligram/Kilogram BI 905681
n=5 participants at risk
Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
50.0%
2/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
60.0%
3/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
60.0%
3/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
60.0%
3/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
50.0%
2/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
60.0%
3/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Chills
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
40.0%
2/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
General disorders
Suprapubic pain
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Investigations
C-telopeptide increased
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
50.0%
2/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
20.0%
1/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
25.0%
1/4 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
0.00%
0/5 • From the first administration of study till the last administration of study drug +42 to 49 days, up to 133 days.
Treated Set (TS): includes all patients who received at least one infusion of BI 905681.
|
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