Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening) (NCT NCT02337283)
NCT ID: NCT02337283
Last Updated: 2026-05-13
Results Overview
Percentage of subjects with drug related adverse events (AEs) in part I is reported
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
From first dose of study medication until 11 days after the last dose of study medication, up to 25 days
Results posted on
2026-05-13
Participant Flow
This Phase I trial evaluated safety, tolerability, and pharmacokinetics of BI 425809 in healthy volunteers: Part 1 tested multiple rising doses (randomized, double-blind, placebo-controlled); Part 2 compared single-dose morning vs evening (randomized, crossover).
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 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
Placebo - BI 425809- Young Healthy Subjects (YH)
Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 milliliter (mL) of water.
|
Placebo - BI 425809- Elderly Healthy Subjects (EH)
Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the morning (Reference (R)) and then single dose of 25 mg of BI 425809 orally in the evening (Test (T)) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the evening (T) and then single dose of 25 mg of BI 425809 orally in the morning (R) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
15
|
6
|
9
|
9
|
9
|
9
|
9
|
9
|
6
|
6
|
|
Overall Study
COMPLETED
|
9
|
14
|
6
|
9
|
9
|
9
|
9
|
8
|
9
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
Placebo - BI 425809- Young Healthy Subjects (YH)
Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 milliliter (mL) of water.
|
Placebo - BI 425809- Elderly Healthy Subjects (EH)
Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the morning (Reference (R)) and then single dose of 25 mg of BI 425809 orally in the evening (Test (T)) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the evening (T) and then single dose of 25 mg of BI 425809 orally in the morning (R) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)
Baseline characteristics by cohort
| Measure |
Placebo - BI 425809- Young Healthy Subjects (YH)
n=15 Participants
Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
Placebo - BI 425809- Elderly Healthy Subjects (EH)
n=6 Participants
Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH
n=6 Participants
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the morning (Reference (R)) and then single dose of 25 mg of BI 425809 orally in the evening (Test (T)) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH
n=6 Participants
Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the evening (T) and then single dose of 25 mg of BI 425809 orally in the morning (R) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 9.2 • n=1512 Participants
|
71.0 Years
STANDARD_DEVIATION 3.5 • n=504 Participants
|
46.0 Years
STANDARD_DEVIATION 7.6 • n=2016 Participants
|
40.3 Years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
70.9 Years
STANDARD_DEVIATION 5.0 • n=97 Participants
|
42.4 Years
STANDARD_DEVIATION 7.2 • n=488 Participants
|
71.1 Years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
34.8 Years
STANDARD_DEVIATION 5.8 • n=9 Participants
|
39.8 Years
STANDARD_DEVIATION 9.1 • n=64 Participants
|
41.8 Years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
42.0 Years
STANDARD_DEVIATION 6.3 • n=55 Participants
|
48.1 Years
STANDARD_DEVIATION 15.2 • n=53 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
3 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=55 Participants
|
29 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
5 Participants
n=99 Participants
|
6 Participants
n=97 Participants
|
7 Participants
n=488 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=9 Participants
|
8 Participants
n=64 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=55 Participants
|
67 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
2 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
9 Participants
n=99 Participants
|
9 Participants
n=97 Participants
|
9 Participants
n=488 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=9 Participants
|
9 Participants
n=64 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=55 Participants
|
94 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
1 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
8 Participants
n=99 Participants
|
9 Participants
n=97 Participants
|
8 Participants
n=488 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=64 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=55 Participants
|
94 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication until 11 days after the last dose of study medication, up to 25 daysPopulation: The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
Percentage of subjects with drug related adverse events (AEs) in part I is reported
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=6 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=15 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I
|
50.0 Percentage of participants
|
46.7 Percentage of participants
|
44.4 Percentage of participants
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
66.7 Percentage of participants
|
88.9 Percentage of participants
|
55.6 Percentage of participants
|
66.7 Percentage of participants
|
PRIMARY outcome
Timeframe: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administrationPopulation: Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints.
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) part II is reported.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=11 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=12 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II
|
8480 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 19.5
|
7000 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 32.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administrationPopulation: Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints.
Maximum measured concentration of the BI 425809 in plasma (Cmax) part II.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=11 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=12 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II
|
277 nmol/L
Geometric Coefficient of Variation 19.8
|
241 nmol/L
Geometric Coefficient of Variation 37.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study medication until 11 days after the last dose of study medication, up to 12 daysPopulation: The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
Percentage of subjects with drug related adverse events (AEs) in part II is reported.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=6 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=6 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administrationPopulation: Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints.
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) part II. After single dosing in the morning as well as in the evening.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=11 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=12 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II
|
10600 nmol*h/L
Geometric Coefficient of Variation 31.5
|
8770 nmol*h/L
Geometric Coefficient of Variation 47.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples were taken at: 2 hours before drug administration and 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24 hours after the drug administration in YH and EH populationPopulation: Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints.
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to 24 hours (AUC0-24) part I. After the first dose.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=9 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I
|
3720 nmol*h/L
Geometric Coefficient of Variation 18.2
|
1410 nmol*h/L
Geometric Coefficient of Variation 20.1
|
3460 nmol*h/L
Geometric Coefficient of Variation 18.5
|
6020 nmol*h/L
Geometric Coefficient of Variation 24.4
|
5620 nmol*h/L
Geometric Coefficient of Variation 17.9
|
7170 nmol*h/L
Geometric Coefficient of Variation 17.9
|
12000 nmol*h/L
Geometric Coefficient of Variation 13.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 528 hours. The details are described in description.Population: Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints.
The AUC of BI 425809 in plasma at steady state over a dosing interval (AUCτ,ss) in Part I was evaluated for all arms achieving steady state. For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to nonlinear pharmacokinetics; therefore, AUCτ,ss was not determined. Instead, AUCτ after the final dose (AUCτ,22) was calculated, representing AUC over one dosing interval (τ; dosing interval) after the last dose on Day 14 (22nd dose), not at steady state. PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-minute time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose. Other arms: 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-minute time points), 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose. Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=8 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) Part I
|
10600 nmol*h/L
Geometric Coefficient of Variation 31.7
|
3870 nmol*h/L
Geometric Coefficient of Variation 22.2
|
11000 nmol*h/L
Geometric Coefficient of Variation 11.6
|
14200 nmol*h/L
Geometric Coefficient of Variation 29.4
|
13900 nmol*h/L
Geometric Coefficient of Variation 30.8
|
16500 nmol*h/L
Geometric Coefficient of Variation 29.6
|
18800 nmol*h/L
Geometric Coefficient of Variation 20.2
|
—
|
—
|
SECONDARY outcome
Timeframe: PK plasma samples were taken at: 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48 and 58 hours after drug administration.Population: Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints.
Maximum measured concentration of the BI 425809 in plasma (Cmax) part I. After the first dose.
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=9 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I
|
278 nmol/L
Geometric Coefficient of Variation 19.7
|
109 nmol/L
Geometric Coefficient of Variation 19.0
|
235 nmol/L
Geometric Coefficient of Variation 18.7
|
397 nmol/L
Geometric Coefficient of Variation 28.7
|
371 nmol/L
Geometric Coefficient of Variation 25.9
|
451 nmol/L
Geometric Coefficient of Variation 17.9
|
884 nmol/L
Geometric Coefficient of Variation 8.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 528 hours. The details are described in description.Population: Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints.
Maximum measured plasma concentration of BI 425809 at steady state over a dosing interval (Cmax,ss) in Part I was evaluated for all treatment arms achieving steady state For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to non-linear pharmacokinetics; therefore, Cmax,ss was not determined. Instead, Cmax after the final dose (Cmax,22) was calculated, representing the maximum observed concentration following the last dose on Day 14 (22nd dose), not at steady-state PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-min time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose Other arms: 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-min time points); 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH
Outcome measures
| Measure |
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=8 Participants
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=9 Participants
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=8 Participants
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 Participants
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) Part I
|
582 nmol/L
Geometric Coefficient of Variation 27.6
|
221 nmol/L
Geometric Coefficient of Variation 19.5
|
618 nmol/L
Geometric Coefficient of Variation 10.9
|
800 nmol/L
Geometric Coefficient of Variation 26.3
|
802 nmol/L
Geometric Coefficient of Variation 25.0
|
1020 nmol/L
Geometric Coefficient of Variation 23.1
|
1930 nmol/L
Geometric Coefficient of Variation 17.2
|
—
|
—
|
Adverse Events
Placebo - BI 425809- Young Healthy Subjects (YH)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo - BI 425809- Elderly Healthy Subjects (EH)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 425809 - 25 mg Multiple Dose in YH
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 425809 - 25 mg Multiple Dose in EH
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 425809 - 50 mg Multiple Dose in YH
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 425809 - 50 mg Multiple Dose in EH
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 425809 - 75 mg Once Daily Multiple Dose in YH
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 425809 - 25 mg Single Dose Morning (R) in YH
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 425809 - 25 mg Single Dose Evening (T) in YH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - BI 425809- Young Healthy Subjects (YH)
n=15 participants at risk
Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
Placebo - BI 425809- Elderly Healthy Subjects (EH)
n=6 participants at risk
Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
|
BI 425809 - 10 Milligram (mg) Multiple Dose in YH
n=9 participants at risk
Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in YH
n=9 participants at risk
Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 25 mg Multiple Dose in EH
n=9 participants at risk
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in YH
n=9 participants at risk
Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 50 mg Multiple Dose in EH
n=9 participants at risk
Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Once Daily Multiple Dose in YH
n=9 participants at risk
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14
|
BI 425809 - 75 mg Twice Daily Multiple Dose in YH
n=9 participants at risk
Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14
|
BI 425809 - 25 mg Single Dose Morning (R) in YH
n=12 participants at risk
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the morning with approximately 240 mL of water.
|
BI 425809 - 25 mg Single Dose Evening (T) in YH
n=11 participants at risk
Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Lacrimation increased
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Ocular discomfort
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Visual acuity reduced transiently
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
44.4%
4/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
2/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
44.4%
4/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Feeling cold
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Feeling drunk
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Puncture site swelling
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Mastitis
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
8.3%
1/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Investigations
Intraocular pressure test
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Disturbance in attention
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
16.7%
1/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
22.2%
2/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
44.4%
4/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
8.3%
1/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
33.3%
3/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/15 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/6 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
11.1%
1/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/9 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/12 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
|
0.00%
0/11 • Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial 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