Trial Outcomes & Findings for A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer (NCT NCT05839600)
NCT ID: NCT05839600
Last Updated: 2026-05-22
Results Overview
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
First treatment cycle, i.e., 21 days.
Results posted on
2026-05-22
Participant Flow
This was an open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of BI 1821736 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 |
BI 1821736 Low Dose
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
8
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
BI 1821736 Low Dose
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Overall Study
Other reason than listed
|
1
|
2
|
|
Overall Study
Objective disease progression
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
4
|
Baseline Characteristics
A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer
Baseline characteristics by cohort
| Measure |
BI 1821736 Low Dose
n=2 Participants
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=8 Participants
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 0.7 • n=2 Participants
|
56.8 years
STANDARD_DEVIATION 18.0 • n=4 Participants
|
54.5 years
STANDARD_DEVIATION 16.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=2 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: First treatment cycle, i.e., 21 days.Population: MTD set: includes all patients in the treated set (TS) who received both doses of the trial medication in the first treatment cycle and were not replaced for the MTD determination.
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period.
Outcome measures
| Measure |
BI 1821736 Low Dose
n=2 Participants
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=6 Participants
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Occurrence of DLTs in the MTD Evaluation Period
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.Population: Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Occurrence of DLTs during the on-treatment period is reported as count of participants with DLTs during the on-treatment period.
Outcome measures
| Measure |
BI 1821736 Low Dose
n=2 Participants
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=8 Participants
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Occurrence of DLTs During the On-treatment Period
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.Population: Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Occurrence of adverse events (AEs) during the on-treatment period is reported as count of participants with AEs during the on-treatment period.
Outcome measures
| Measure |
BI 1821736 Low Dose
n=2 Participants
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=8 Participants
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Occurrence of AEs During the On-treatment Period
|
2 Participants
|
8 Participants
|
Adverse Events
BI 1821736 Low Dose
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1821736 High Dose
Serious events: 6 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
BI 1821736 Low Dose
n=2 participants at risk
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=8 participants at risk
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
4/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
Other adverse events
| Measure |
BI 1821736 Low Dose
n=2 participants at risk
Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
BI 1821736 High Dose
n=8 participants at risk
Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Chills
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Fatigue
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Influenza like illness
|
50.0%
1/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
4/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
37.5%
3/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • "All-Cause Mortality": Up to 15 months from start of study treatment administration. "Serious Adverse Events", "Other Adverse Events": From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Treated set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
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