Trial Outcomes & Findings for A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease (NCT NCT04750577)
NCT ID: NCT04750577
Last Updated: 2024-07-23
Results Overview
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.
Results posted on
2024-07-23
Participant Flow
This study was a phase II, randomized, double-blind (within dose groups), placebo controlled and parallel group trial in patients with diabetic kidney disease (DKD) to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo.
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 685509 1 mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
61
|
60
|
|
Overall Study
Treated
|
61
|
61
|
61
|
58
|
|
Overall Study
COMPLETED
|
55
|
46
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
15
|
14
|
7
|
Reasons for withdrawal
| Measure |
BI 685509 1 mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
10
|
8
|
1
|
|
Overall Study
Change of residence
|
0
|
0
|
1
|
0
|
|
Overall Study
Burden of study procedures
|
0
|
2
|
2
|
0
|
|
Overall Study
Prematurely discontinued
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol deviation
|
1
|
1
|
1
|
1
|
|
Overall Study
Other than listed
|
3
|
2
|
2
|
1
|
|
Overall Study
Not treated
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
Baseline characteristics by cohort
| Measure |
BI 685509 1 mg TID
n=61 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=61 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
n=61 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=60 Participants
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.2 Years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
64.8 Years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
65.2 Years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
67.6 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
65.7 Years
STANDARD_DEVIATION 9.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
59 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
184 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
162 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
127 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Urine Albumin Creatinine Ratio (UACR) FMV
|
991.7 Milligram/gram (mg/g)
STANDARD_DEVIATION 889.0 • n=99 Participants
|
1033 Milligram/gram (mg/g)
STANDARD_DEVIATION 760.4 • n=107 Participants
|
818.4 Milligram/gram (mg/g)
STANDARD_DEVIATION 686.9 • n=206 Participants
|
866.1 Milligram/gram (mg/g)
STANDARD_DEVIATION 658.1 • n=7 Participants
|
927.5 Milligram/gram (mg/g)
STANDARD_DEVIATION 754.8 • n=31 Participants
|
|
Urine Albumin Creatinine Ratio (UACR) - 10 Hour
|
1093.5 milligram/gram (mg/g)
STANDARD_DEVIATION 980.3 • n=99 Participants
|
1090.7 milligram/gram (mg/g)
STANDARD_DEVIATION 794.4 • n=107 Participants
|
880.8 milligram/gram (mg/g)
STANDARD_DEVIATION 722.4 • n=206 Participants
|
913.1 milligram/gram (mg/g)
STANDARD_DEVIATION 657.3 • n=7 Participants
|
994.9 milligram/gram (mg/g)
STANDARD_DEVIATION 799.5 • n=31 Participants
|
PRIMARY outcome
Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.Population: Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6.
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported.
Outcome measures
| Measure |
BI 685509 1 mg TID
n=57 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=53 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
n=56 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=56 Participants
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment
|
-0.069 milligram/gram (mg/g)
Standard Error 0.074
|
-0.029 milligram/gram (mg/g)
Standard Error 0.079
|
-0.217 milligram/gram (mg/g)
Standard Error 0.076
|
0.034 milligram/gram (mg/g)
Standard Error 0.073
|
SECONDARY outcome
Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.Population: Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6.
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported.
Outcome measures
| Measure |
BI 685509 1 mg TID
n=57 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=53 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
n=56 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=56 Participants
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void Urine After 20 Weeks of Trial Treatment
|
-0.112 milligram/gram (mg/g)
Standard Error 0.072
|
-0.020 milligram/gram (mg/g)
Standard Error 0.076
|
-0.258 milligram/gram (mg/g)
Standard Error 0.074
|
0.099 milligram/gram (mg/g)
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Baseline (day -14 and -7) and week 20 (day 141).Population: Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6.
Number of patients achieving Urine Albumin Creatinine Ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.
Outcome measures
| Measure |
BI 685509 1 mg TID
n=57 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=53 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
n=56 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=56 Participants
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment
|
23 Participants
|
16 Participants
|
26 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (day -14 and -7) and week 20 (day 141).Population: Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6.
Number of patients achieving Albumin Creatinine Ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.
Outcome measures
| Measure |
BI 685509 1 mg TID
n=57 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=53 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3 mg TID
n=56 Participants
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=56 Participants
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment
|
23 Participants
|
13 Participants
|
29 Participants
|
11 Participants
|
Adverse Events
BI 685509 1 mg TID
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
BI 685509 2mg TID
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
BI 685509 3mg TID
Serious events: 7 serious events
Other events: 15 other events
Deaths: 2 deaths
Placebo
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 685509 1 mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=58 participants at risk
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.7%
1/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.7%
1/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.7%
1/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
General disorders
Peripheral swelling
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
Influenza
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Investigations
Protein urine present
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.7%
1/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
Other adverse events
| Measure |
BI 685509 1 mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 2mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
BI 685509 3mg TID
n=61 participants at risk
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20.
The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
Placebo
n=58 participants at risk
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
4/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.6%
1/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
6.9%
4/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
General disorders
Oedema peripheral
|
3.3%
2/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
8.2%
5/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
8.2%
5/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
1.7%
1/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Infections and infestations
COVID-19
|
3.3%
2/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
4.9%
3/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
4.9%
3/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
5.2%
3/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Vascular disorders
Hypertension
|
4.9%
3/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
3.3%
2/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
4.9%
3/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
10.3%
6/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
|
Vascular disorders
Hypotension
|
4.9%
3/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
9.8%
6/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
8.2%
5/61 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
0.00%
0/58 • From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
|
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