Trial Outcomes & Findings for A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood (NCT NCT03817476)
NCT ID: NCT03817476
Last Updated: 2026-04-24
Results Overview
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 72 hours (AUC0-72). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.
Results posted on
2026-04-24
Participant Flow
The trial was performed as a randomised, open-label, three-treatment, three-period, six-sequence crossover trial in healthy male and female subjects in order to compare the test treatments (T1 and T2) to each other and to the reference treatment (R).
All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Treatment Sequence A: TF2/iCF1/iCF2
TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
TF=Tablet formulation, iCF=Intended commercial formulation.
|
Treatment Sequence B: iCF1/iCF2/TF2
iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence C: iCF2/TF2/iCF1
iCF2(T2):One 25 milligram (mg) BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence D: TF2/iCF2/iCF1
TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence E: iCF1/TF2/iCF2
iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence F: iCF2/iCF1/TF2
iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
|---|---|---|---|---|---|---|
|
Treatment period 1 (3.5 days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 1 (3.5 days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 1 (3.5 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment period 2 (3.5 days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 2 (3.5 days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 2 (3.5 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment period 3 (3.5 days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 3 (3.5 days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment period 3 (3.5 days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood
Baseline characteristics by cohort
| Measure |
Treatment Sequence A: TF2/iCF1/iCF2
n=3 Participants
TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
TF=Tablet formulation, iCF=Intended commercial formulation.
|
Treatment Sequence B: iCF1/iCF2/TF2
n=3 Participants
iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence C: iCF2/TF2/iCF1
n=3 Participants
iCF2(T2):One 25 milligram (mg) BI 425809 iCF2 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence D: TF2/iCF2/iCF1
n=3 Participants
TF2(R):One 25 milligram (mg) BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 mg BI 425809 iCF1 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence E: iCF1/TF2/iCF2
n=3 Participants
iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet - iCF2(T2):One 25 mg BI 425809 iCF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Treatment Sequence F: iCF2/iCF1/TF2
n=3 Participants
iCF2(T2):One 25 mg BI 425809 iCF2 tablet - iCF1(T1):One 25 milligram (mg) BI 425809 iCF1 tablet - TF2(R):One 25 mg BI 425809 TF2 tablet. All treatments: Oral with 240 milliliter of water after an overnight fast of at least 10 hours. There was a washout period of 14 days between treatments.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 Years
STANDARD_DEVIATION 4.4 • n=2 Participants
|
45.0 Years
STANDARD_DEVIATION 7.2 • n=1 Participants
|
37.3 Years
STANDARD_DEVIATION 5.8 • n=3 Participants
|
42.0 Years
STANDARD_DEVIATION 8.7 • n=24 Participants
|
41.0 Years
STANDARD_DEVIATION 11.0 • n=2 Participants
|
43.7 Years
STANDARD_DEVIATION 14.0 • n=2 Participants
|
42.3 Years
STANDARD_DEVIATION 8.1 • n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
9 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
9 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
18 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=2 Participants
|
3 Participants
n=2 Participants
|
18 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.Population: PKS (Pharmacokinetic parameter analysis set) included all subjects in the TS (treated set) who provided at least 1 primary pharmacokinetic (PK) endpoint that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). Descriptive and model based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 72 hours (AUC0-72). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'.
Outcome measures
| Measure |
iCF1(T1) 25 Milligram BI 425809
n=18 Participants
iCF1(T1):One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. iCF=Intended commercial formulation
|
iCF2(T2) 25 Milligram BI 425809
n=18 Participants
iCF2(T2):One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.
|
TF2(R) 25 Milligram BI 425809
n=18 Participants
TF2(R): One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. TF=Tablet formulation.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
|
7904.16 nanomol (nmol) * hour (h) per Liter (L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
6400.59 nanomol (nmol) * hour (h) per Liter (L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
7648.23 nanomol (nmol) * hour (h) per Liter (L)
Standard Error NA
Adjusted geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.Population: PKS (Pharmacokinetic parameter analysis set) included all subjects in the TS (treated set) who provided at least 1 primary pharmacokinetic (PK) endpoint that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). Descriptive and model based analyses of PK parameters were based on the PKS.
Cmax represents maximum measured concentration of BI 425809 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'.
Outcome measures
| Measure |
iCF1(T1) 25 Milligram BI 425809
n=18 Participants
iCF1(T1):One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. iCF=Intended commercial formulation
|
iCF2(T2) 25 Milligram BI 425809
n=18 Participants
iCF2(T2):One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.
|
TF2(R) 25 Milligram BI 425809
n=18 Participants
TF2(R): One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. TF=Tablet formulation.
|
|---|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
276.70 nanomol (nmol) / Litre (L)
Standard Error NA
Adjusted geometric standard error = 1.05
|
220.87 nanomol (nmol) / Litre (L)
Standard Error NA
Adjusted geometric standard error = 1.05
|
246.73 nanomol (nmol) / Litre (L)
Standard Error NA
Adjusted geometric standard error = 1.05
|
Adverse Events
iCF1(T1) 25 Milligram BI 425809
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
iCF2(T2) 25 Milligram BI 425809
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TF2(R) 25 Milligram BI 425809
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iCF1(T1) 25 Milligram BI 425809
n=18 participants at risk
iCF1(T1):One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. iCF=Intended commercial formulation
|
iCF2(T2) 25 Milligram BI 425809
n=18 participants at risk
iCF2(T2):One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.
|
TF2(R) 25 Milligram BI 425809
n=18 participants at risk
TF2(R): One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours. TF=Tablet formulation.
|
|---|---|---|---|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
0.00%
0/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
5.6%
1/18 • Adverse events: from the intake of trial medication till the end of the residual effect period, up to 11 days for each arm/ reporting group. All-cause mortality: Up to 20 days.
Treated set (TS): The treated set includes all subjects in the randomised set (RS) who were treated with at least one dose of study drug.
|
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
- Publication restrictions are in place