Trial Outcomes & Findings for A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy (NCT NCT06528093)
NCT ID: NCT06528093
Last Updated: 2026-07-15
Results Overview
All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination. The MTD evaluation period was defined as the first two treatment cycles; i.e. from Cycle 1 Day 1 (C1D1) up to and including the day before C3D1, or to the end of the REP in case of discontinuation before the start of C3.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.
Results posted on
2026-07-15
Participant Flow
This open-label, non-randomized, first-in-human Phase Ia/Ib study evaluated BI 765883 as monotherapy and in combination with gemcitabine and nab-paclitaxel in patients with metastatic or relapsed pancreatic ductal adenocarcinoma. The study included dose escalation and planned expansion phases.
The study was discontinued after safety concerns were observed at Dose Level 1 (DL1) in the combination cohort (BI 765883 0.4 mg/kg plus chemotherapy). A maximum tolerated dose (MTD) and a recommended dose for expansion (RDE) were not identified, and the planned Phase Ib expansion phase was not completed.
Participant milestones
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Clinical Disease Progression
|
0
|
1
|
0
|
|
Overall Study
Objective Disease Progression
|
2
|
2
|
2
|
Baseline Characteristics
A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
Baseline characteristics by cohort
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 1.4 • n=20 Participants
|
64.0 Years
STANDARD_DEVIATION 2.6 • n=20 Participants
|
61.0 Years
STANDARD_DEVIATION 9.8 • n=40 Participants
|
62.6 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The MTD evaluation period corresponds to the first two treatment cycles (28 days), with extension up to 35 days in cases of early discontinuation, based on the residual effect period.Population: MTD evaluation set (MTDS): This includes all patients in the Treatment Set (TS) who were not replaced for the Maximum Tolerated Dose (MTD) determination.
All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination. The MTD evaluation period was defined as the first two treatment cycles; i.e. from Cycle 1 Day 1 (C1D1) up to and including the day before C3D1, or to the end of the REP in case of discontinuation before the start of C3.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Occurrence of Dose-Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period for the Determination of the Maximum Tolerated Dose (MTD)
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.Population: Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
Objective Response is defined as the best overall response of complete response (CR) or partial response (PR), recorded from the start of the study treatment until the earliest of disease progression, death, or last evaluable tumor assessment, and before start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Progressive Disease
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Stable Disease
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Not Evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.Population: Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
Disease control (DC) was defined as complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) from the start of treatment until the earliest of progressive disease (PD), death, or the last evaluable tumor assessment and before the start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Disease Control as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
No
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Disease Control as Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Yes
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.Population: Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
Objective response (OR) is defined as the best overall response of complete response (CR) or partial response (PR), recorded from the start of the study treatment until the earliest of progressive disease (PD), death, or the last evaluable tumor assessment, and before the start of subsequent anti-cancer therapy.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Objective Response (OR) as Assessed by the Investigator Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
No
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Objective Response (OR) as Assessed by the Investigator Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.Population: Pharmacokinetic parameter analysis set (PKS): This includes all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The maximum measured concentration of the BI 765883 in serum is reported.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Maximum Measured Concentration of BI 765883 in Serum (Cmax)
Cycle 1
|
7900 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 3.40
|
27000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21.2
|
9020 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 16.8
|
|
Maximum Measured Concentration of BI 765883 in Serum (Cmax)
Cycle 4
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation na
Descriptive statistics for PK parameters are calculated if N\>=2.
|
38400 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 0.737
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected predose (336 hrs after infusion start, prior to the next dose), at the start of infusion (0 hrs), after the end of infusion (0.5 hrs), and at 5, 24, 48, and 168 hrs after infusion start in Cycle 1 and Cycle 4.Population: Pharmacokinetic parameter analysis set (PKS): This includes all subjects in the treated set (TS) who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
The area under the serum concentration time curve of BI 765883 from time 0 to 336 hours is reported.
Outcome measures
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 Participants
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 Participants
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 Participants
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve of BI 765883 From Time 0 to 336 Hours (AUC₀-336)
Cycle 1
|
674000 hours * nanograms per milliliter
Geometric Coefficient of Variation 12.1
|
3350000 hours * nanograms per milliliter
Geometric Coefficient of Variation 4.86
|
904000 hours * nanograms per milliliter
Geometric Coefficient of Variation 5.05
|
|
Area Under the Concentration-Time Curve of BI 765883 From Time 0 to 336 Hours (AUC₀-336)
Cycle 4
|
NA hours * nanograms per milliliter
Geometric Coefficient of Variation na
Descriptive statistics for PK parameters are calculated if N\>=2.
|
6660000 hours * nanograms per milliliter
Geometric Coefficient of Variation 12.8
|
—
|
Adverse Events
BI 765883 0.4 mg/kg, Monotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
BI 765883 1.3 mg/kg, Monotherapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
BI 765883 0.4 mg/kg + Chemotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 participants at risk
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 participants at risk
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 participants at risk
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Disease progression
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Nervous system disorders
Toxic encephalopathy
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
Other adverse events
| Measure |
BI 765883 0.4 mg/kg, Monotherapy
n=2 participants at risk
Participants received BI 765883 at a dose of 0.4 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 1.3 mg/kg, Monotherapy
n=3 participants at risk
Participants received BI 765883 at a dose of 1.3 mg/kg, administered intravenously over a 30-minute infusion on Day 1 of each 2-week cycle.
|
BI 765883 0.4 mg/kg + Chemotherapy
n=3 participants at risk
Participants received BI 765883 at 0.4 mg/kg intravenously every 2 weeks as a 30-minute infusion. In addition, gemcitabine (1000 mg/m²) and nab-paclitaxel (125 mg/m²) were administered intravenously as 30-minute infusions on Day 1 of each 2-week cycle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
100.0%
2/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
66.7%
2/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
66.7%
2/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
100.0%
3/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Chills
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Infections and infestations
Coronavirus infection
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Infections and infestations
Penile infection
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Investigations
Weight decreased
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
66.7%
2/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Cardiac disorders
Atrial fibrillation
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Psychiatric disorders
Paranoia
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Renal and urinary disorders
Urinary retention
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
0.00%
0/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
33.3%
1/3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) collection period: From the first trial drug administration until 35 days (the Residual Effect Period) after the last trial drug administration, covering a total duration of up to 134 days.
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 765883.
|
Additional Information
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