Trial Outcomes & Findings for A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis (NCT NCT05213624)

Last Updated: 2026-01-12

Results Overview

Predicted probability of patients as a percentage - predicted percentage of patients - achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 12 (responders) is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders. The predicted probability of response was calculated using a logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates and is presented as a percentage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

At baseline and Week 12.

Results posted on

2026-01-12

Participant Flow

Randomized, double-blind, parallel group trial to assess the efficacy of 3 doses of BI 764198 (20 mg, 40 mg, and 80 mg) compared to placebo in patients with primary focal segmental glomerulosclerosis (FSGS), or patients with monogenic FSGS as a result of TRPC6 mutations.

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

Participant milestones
Measure	BI 764198 20 mg Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Overall Study STARTED	18	16	17	16
Overall Study Treated	18	15	15	14
Overall Study COMPLETED	18	10	15	13
Overall Study NOT COMPLETED	0	6	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 764198 40 mg Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Overall Study Adverse Event	3	0	0
Overall Study Protocol deviation	2	0	0
Overall Study Withdrawal by Subject	0	0	1
Overall Study Not treated	1	2	2

Baseline Characteristics

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 764198 20 mg n=18 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=15 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=15 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=14 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.	Total n=62 Participants Total of all reporting groups
Age, Continuous	41.2 Years STANDARD_DEVIATION 15.0 • n=210 Participants	39.8 Years STANDARD_DEVIATION 13.8 • n=19 Participants	39.8 Years STANDARD_DEVIATION 10.5 • n=8 Participants	42.2 Years STANDARD_DEVIATION 11.1 • n=24 Participants	40.7 Years STANDARD_DEVIATION 12.6 • n=5716 Participants
Sex: Female, Male Female	9 Participants n=210 Participants	7 Participants n=19 Participants	2 Participants n=8 Participants	7 Participants n=24 Participants	25 Participants n=5716 Participants
Sex: Female, Male Male	9 Participants n=210 Participants	8 Participants n=19 Participants	13 Participants n=8 Participants	7 Participants n=24 Participants	37 Participants n=5716 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=210 Participants	2 Participants n=19 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	10 Participants n=5716 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=210 Participants	13 Participants n=19 Participants	13 Participants n=8 Participants	14 Participants n=24 Participants	52 Participants n=5716 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=5716 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=5716 Participants
Race (NIH/OMB) Asian	3 Participants n=210 Participants	3 Participants n=19 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	12 Participants n=5716 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=210 Participants	0 Participants n=19 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=5716 Participants
Race (NIH/OMB) Black or African American	2 Participants n=210 Participants	0 Participants n=19 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=5716 Participants
Race (NIH/OMB) White	11 Participants n=210 Participants	10 Participants n=19 Participants	9 Participants n=8 Participants	9 Participants n=24 Participants	39 Participants n=5716 Participants
Race (NIH/OMB) More than one race	1 Participants n=210 Participants	2 Participants n=19 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=5716 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=5716 Participants
Urine Protein-Creatinine Ratio (UPCR) from 24-hour Urine	4.4865 Ratio STANDARD_DEVIATION 3.0188 • n=210 Participants	4.0508 Ratio STANDARD_DEVIATION 3.0012 • n=19 Participants	2.6767 Ratio STANDARD_DEVIATION 2.2209 • n=8 Participants	4.5166 Ratio STANDARD_DEVIATION 2.9342 • n=24 Participants	3.9709 Ratio STANDARD_DEVIATION 2.8565 • n=5716 Participants

PRIMARY outcome

Timeframe: At baseline and Week 12.

Population: Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders and were included in the analysis.

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=18 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=14 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=14 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=14 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12	48.9 Predicted percentage of patients Interval 29.2 to 68.6	16.0 Predicted percentage of patients Interval -1.5 to 33.5	38.5 Predicted percentage of patients Interval 12.2 to 64.8	11.4 Predicted percentage of patients Interval -2.3 to 25.2

PRIMARY outcome

Timeframe: At baseline and at Week 12.

Relative change from baseline at Week 12 in 24-hour urine protein creatinine ratio (UPCR), is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). An analysis of covariance (ANCOVA) model was used to estimate the relative change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=16 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=10 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=13 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=11 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR)	-38.44 Percentage of change in 24-hour UPCR Interval -50.41 to -23.6	-2.39 Percentage of change in 24-hour UPCR Interval -24.5 to 26.19	-21.52 Percentage of change in 24-hour UPCR Interval -39.18 to 1.27	2.28 Percentage of change in 24-hour UPCR Interval -20.2 to 31.09

SECONDARY outcome

Timeframe: At Week 1 and Week 12.

Median change in 24-hour urine protein creatinine ratio (UPCR) relative to Visit 3 (Week 1) at Week 12, is calculated by subtracting the 24-hour UPCR, \[Week 12\] - \[Week 1\] values per patient, then by calculating the median of these changes, per treatment group.

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=15 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=10 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=12 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=10 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12	-0.035 grams/grams Interval -0.812 to 0.669	0.712 grams/grams Interval -0.169 to 0.926	-0.4435 grams/grams Interval -0.837 to 0.1795	0.106 grams/grams Interval -0.496 to 0.497

SECONDARY outcome

Timeframe: At baseline and at Week 13.

Median change in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 13, is calculated by subtracting the 24-hour UPCR, \[Week 13\] - \[baseline\] values per patient,then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=17 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=13 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=12 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=13 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13	-0.4985 grams/grams Interval -0.808 to 0.505	-0.151 grams/grams Interval -0.6945 to 0.765	-0.3033 grams/grams Interval -0.5875 to 0.383	0.0795 grams/grams Interval -0.441 to 1.4615

SECONDARY outcome

Timeframe: At baseline and at Week 12.

Population: Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Patients, who either missed their Week 12 urinary excretion rate measure or their Week 12 urinary excretion rate measure occurred later than 5 days after the last dose (Residual Effect Period), were not included in this analysis.

Median change in 24-hour urinary excretion rate relative to baseline at Week 12, is calculated by subtracting the urinary excretion rate, \[Week 12\] - \[baseline\], values per patient, then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=16 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=10 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=13 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=11 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12	-0.5036 grams/day Interval -1.6342 to -0.1112	-0.4056 grams/day Interval -1.0535 to 0.6168	-0.8967 grams/day Interval -1.0484 to -0.0975	0.0809 grams/day Interval -0.8115 to 1.7913

SECONDARY outcome

Timeframe: At 671.917 hours and at 2015.917 hours after first drug administration.

Population: All patients who received at least one dose of trial medication and who provide at least one pre-dose concentration that was not excluded due to protocol violation relevant to the evaluation of pharmacokinetics (PK) or due to PK non-evaluability. Patients with no available pre-dose concentration were not included in the analysis.

Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported.

Outcome measures

Outcome measures
Measure	BI 764198 20 mg n=16 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=13 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=14 Participants Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12 Week 4	119 nanomole/liter Geometric Coefficient of Variation 47.2	266 nanomole/liter Geometric Coefficient of Variation 64.7	683 nanomole/liter Geometric Coefficient of Variation 66.5	—
Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12 Week 12	114 nanomole/liter Geometric Coefficient of Variation 85.9	328 nanomole/liter Geometric Coefficient of Variation 64.6	509 nanomole/liter Geometric Coefficient of Variation 45.7	—

Adverse Events

BI 764198 20 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

BI 764198 40 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

BI 764198 80 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BI 764198 20 mg n=18 participants at risk Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 40 mg n=15 participants at risk Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.	BI 764198 80 mg n=15 participants at risk Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.	Placebo n=14 participants at risk Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
General disorders Oedema	5.6% 1/18 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/14 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.
Investigations Blood creatinine increased	0.00% 0/18 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	6.7% 1/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/14 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	5.6% 1/18 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/14 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	5.6% 1/18 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/14 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.
Vascular disorders Hypertension	0.00% 0/18 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	0.00% 0/15 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.	7.1% 1/14 • All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks. Treated set (TS): all patients who received at least one dose of trial medication.

Other adverse events

Additional Information

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