Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 (NCT NCT02362516)
NCT ID: NCT02362516
Last Updated: 2026-05-01
Results Overview
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
Results posted on
2026-05-01
Participant Flow
The trial applied a non-randomised, open label, sequential-group, multiple-dose design. Participants were allocated to 4 dose groups of 6 participants each. Each participant was treated once daily for 14 days.
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 425809 5 mg
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
8
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 425809 5 mg
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Baseline characteristics by cohort
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=8 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 Years
STANDARD_DEVIATION 12.9 • n=14 Participants
|
44.0 Years
STANDARD_DEVIATION 11.5 • n=34 Participants
|
47.1 Years
STANDARD_DEVIATION 6.9 • n=69 Participants
|
40.2 Years
STANDARD_DEVIATION 10.6 • n=140 Participants
|
42.7 Years
STANDARD_DEVIATION 10.4 • n=451 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
6 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
5 Participants
n=140 Participants
|
25 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.Population: The PK analysis set (PKS) included all subjects from the Treated Set (TS) who provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).
Outcome measures
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=7 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)
|
421.0 nanomole*hours/Liter (nmol∙h/L)
Geometric Coefficient of Variation 17.6
|
829 nanomole*hours/Liter (nmol∙h/L)
Geometric Coefficient of Variation 18.9
|
1840.0 nanomole*hours/Liter (nmol∙h/L)
Geometric Coefficient of Variation 24.2
|
3300.0 nanomole*hours/Liter (nmol∙h/L)
Geometric Coefficient of Variation 29.3
|
PRIMARY outcome
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.Population: PKS. Only participants with evaluable results for this PK parameter are reported.
Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).
Outcome measures
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=6 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)
|
29.9 nmol∙h/L
Geometric Coefficient of Variation 15.4
|
59.8 nmol∙h/L
Geometric Coefficient of Variation 19.3
|
124.0 nmol∙h/L
Geometric Coefficient of Variation 27.2
|
260.0 nmol∙h/L
Geometric Coefficient of Variation 29.1
|
PRIMARY outcome
Timeframe: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).Population: PKS. Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.
Outcome measures
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=7 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
42.3 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 23.2
|
85.6 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 19.5
|
176 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 22.6
|
328 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 37.5
|
PRIMARY outcome
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.Population: PKS. Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of BI 425809 in CSF is reported.
Outcome measures
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=7 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 425809 in CSF (Cmax)
|
2.91 nmol/L
Geometric Coefficient of Variation 21.3
|
5.59 nmol/L
Geometric Coefficient of Variation 17.5
|
12.2 nmol/L
Geometric Coefficient of Variation 26.4
|
25.0 nmol/L
Geometric Coefficient of Variation 37.5
|
PRIMARY outcome
Timeframe: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.Population: PKS. Only participants with evaluable results for this PK parameter are reported.
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Outcome measures
| Measure |
BI 425809 5 mg
n=5 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=4 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=8 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)
|
66.7 nmol/L
Geometric Coefficient of Variation 40.9
|
107 nmol/L
Geometric Coefficient of Variation 48.2
|
266 nmol/L
Geometric Coefficient of Variation 38.4
|
445 nmol/L
Geometric Coefficient of Variation 50.3
|
PRIMARY outcome
Timeframe: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.Population: PKS. Only participants with evaluable results for this PK parameter are reported.
Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.
Outcome measures
| Measure |
BI 425809 5 mg
n=5 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=4 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=6 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Concentration of BI 425809 in CSF at the Time Point 312h (C312)
|
5.62 nmol/L
Geometric Coefficient of Variation 51.8
|
9.67 nmol/L
Geometric Coefficient of Variation 41.9
|
21.7 nmol/L
Geometric Coefficient of Variation 33.2
|
42.4 nmol/L
Geometric Coefficient of Variation 36.7
|
SECONDARY outcome
Timeframe: From the first drug administration until 11 days after the last drug administration, up to 30days.Population: Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
Percentage of participants with drug-related adverse events (AEs).
Outcome measures
| Measure |
BI 425809 5 mg
n=6 Participants
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
BI 425809 10 mg
n=6 Participants
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=8 Participants
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 Participants
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events (AEs)
|
0 Percentage of participants
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
BI 425809 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 425809 25 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 425809 50 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 425809 5 mg
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 |
BI 425809 10 mg
n=6 participants at risk
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
|
BI 425809 25 mg
n=8 participants at risk
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
|
BI 425809 50 mg
n=5 participants at risk
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
|
BI 425809 5 mg
n=6 participants at risk
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
|
|---|---|---|---|---|
|
Infections and infestations
Gingivitis
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
20.0%
1/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
25.0%
2/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
25.0%
2/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
50.0%
4/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
20.0%
1/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
50.0%
3/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
20.0%
1/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
20.0%
1/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
66.7%
4/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
62.5%
5/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
60.0%
3/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
66.7%
4/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
16.7%
1/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
12.5%
1/8 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/5 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
|
0.00%
0/6 • From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 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 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