Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults (NCT NCT03522506)
NCT ID: NCT03522506
Last Updated: 2021-03-26
Results Overview
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Day 1: 2 hours post-infusion start
Results posted on
2021-03-26
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 09 May 2018 to 07 November 2018.
Healthy sleep deprived participants were enrolled in 1 of the 4 treatment sequences of this 4-period crossover study to receive: TAK 925 44 milligram (mg) (Low dose), TAK-925 112 mg (High dose), modafinil 300 mg, and placebo.
Participant milestones
| Measure |
TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg
TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 4.
|
TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo
TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 4.
|
Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg
Placebo, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
|---|---|---|---|---|
|
Treatment Period 1 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
|
Treatment Period 1 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Treatment Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (7 Days)
STARTED
|
5
|
5
|
5
|
5
|
|
Washout Period 1 (7 Days)
COMPLETED
|
5
|
5
|
5
|
4
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (2 Days)
STARTED
|
5
|
5
|
5
|
4
|
|
Treatment Period 2 (2 Days)
COMPLETED
|
5
|
5
|
5
|
4
|
|
Treatment Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (7 Days)
STARTED
|
5
|
5
|
5
|
4
|
|
Washout Period 2 (7 Days)
COMPLETED
|
5
|
5
|
5
|
3
|
|
Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period 3 (2 Days)
STARTED
|
5
|
5
|
5
|
3
|
|
Treatment Period 3 (2 Days)
COMPLETED
|
5
|
5
|
5
|
3
|
|
Treatment Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (7 Days)
STARTED
|
5
|
5
|
5
|
3
|
|
Washout Period 3 (7 Days)
COMPLETED
|
5
|
5
|
5
|
3
|
|
Washout Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4 (2 Days)
STARTED
|
5
|
5
|
5
|
3
|
|
Treatment Period 4 (2 Days)
COMPLETED
|
5
|
5
|
5
|
3
|
|
Treatment Period 4 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg
TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 4.
|
TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo
TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 4.
|
Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg
Placebo, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
|---|---|---|---|---|
|
Washout Period 1 (7 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (7 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
Baseline characteristics by cohort
| Measure |
TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg
n=5 Participants
TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 4.
|
TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo
n=5 Participants
TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 4.
|
Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg
n=5 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg
n=5 Participants
Placebo, once on Day 1 of Treatment Period 1, followed by a minimum of 7-days washout period, further followed by modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 44 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 112 mg, injection, intravenously, administered as 9-hour infusion, once on Day 1 of Treatment Period 4.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 4.55 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 3.78 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 3.44 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 1.22 • n=4 Participants
|
26.9 years
STANDARD_DEVIATION 3.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Weight
|
82.6 kilogram (kg)
STANDARD_DEVIATION 11.10 • n=5 Participants
|
78.8 kilogram (kg)
STANDARD_DEVIATION 6.52 • n=7 Participants
|
84.2 kilogram (kg)
STANDARD_DEVIATION 10.73 • n=5 Participants
|
83.0 kilogram (kg)
STANDARD_DEVIATION 11.59 • n=4 Participants
|
82.2 kilogram (kg)
STANDARD_DEVIATION 9.58 • n=21 Participants
|
|
Height
|
182.1 centimeter (cm)
STANDARD_DEVIATION 5.32 • n=5 Participants
|
176.1 centimeter (cm)
STANDARD_DEVIATION 5.83 • n=7 Participants
|
175.6 centimeter (cm)
STANDARD_DEVIATION 8.60 • n=5 Participants
|
175.2 centimeter (cm)
STANDARD_DEVIATION 4.70 • n=4 Participants
|
177.3 centimeter (cm)
STANDARD_DEVIATION 6.46 • n=21 Participants
|
|
Body mass index (BMI)
|
24.9 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.95 • n=5 Participants
|
25.4 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.31 • n=7 Participants
|
27.2 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.67 • n=5 Participants
|
27.0 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.89 • n=4 Participants
|
26.1 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.36 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: 2 hours post-infusion startPopulation: Pharmacodynamics (PD) analysis set: all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from MWT, polysomnography (PSG), Karolinska Sleepiness Scale (KSS), or Cambridge Cognition Computerized Battery of Tests (CCBT). PD analysis set where data at specified time points was available.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start
|
15.68 minute
Standard Error 2.305
|
35.74 minute
Standard Error 2.445
|
40.02 minute
Standard Error 2.445
|
35.57 minute
Standard Error 2.368
|
PRIMARY outcome
Timeframe: Day 1: 4 hours post-infusion startPopulation: The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start
|
9.10 minute
Standard Error 2.186
|
32.04 minute
Standard Error 2.320
|
40.05 minute
Standard Error 2.320
|
35.60 minute
Standard Error 2.246
|
PRIMARY outcome
Timeframe: Day 1: 6 hours post-infusion startPopulation: The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start
|
6.15 minute
Standard Error 2.589
|
20.71 minute
Standard Error 2.742
|
38.36 minute
Standard Error 2.742
|
31.89 minute
Standard Error 2.659
|
PRIMARY outcome
Timeframe: Day 1: 8 hours post-infusion startPopulation: The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start
|
3.53 minute
Standard Error 2.146
|
13.13 minute
Standard Error 2.279
|
36.86 minute
Standard Error 2.279
|
20.44 minute
Standard Error 2.206
|
PRIMARY outcome
Timeframe: Day 1: 1 hour post-end of infusionPopulation: The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion
|
4.65 minute
Standard Error 2.109
|
2.49 minute
Standard Error 2.241
|
2.36 minute
Standard Error 2.241
|
21.42 minute
Standard Error 2.168
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
940.4 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 127.26
|
2303.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 174.23
|
—
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II
M-I
|
572.0 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 196.75
|
1368.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 489.96
|
—
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II
M-II
|
12.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 7.91
|
30.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 19.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
963.7 h*ng/mL
Standard Deviation 134.70
|
2368.7 h*ng/mL
Standard Deviation 185.04
|
—
|
—
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II
M-I
|
586.8 h*ng/mL
Standard Deviation 204.08
|
1405.6 h*ng/mL
Standard Deviation 510.25
|
—
|
—
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II
M-II
|
15.2 h*ng/mL
Standard Deviation 7.38
|
32.0 h*ng/mL
Standard Deviation 20.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
105.8 nanogram per milliliter (ng/mL)
Standard Deviation 11.74
|
266.0 nanogram per milliliter (ng/mL)
Standard Deviation 40.10
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II
M-I
|
61.9 nanogram per milliliter (ng/mL)
Standard Deviation 21.41
|
144.7 nanogram per milliliter (ng/mL)
Standard Deviation 55.64
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II
M-II
|
1.3 nanogram per milliliter (ng/mL)
Standard Deviation 0.88
|
3.2 nanogram per milliliter (ng/mL)
Standard Deviation 2.32
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
103.4 ng/mL
Standard Deviation 14.21
|
253.4 ng/mL
Standard Deviation 34.35
|
—
|
—
|
|
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II
M-I
|
64.0 ng/mL
Standard Deviation 21.25
|
151.1 ng/mL
Standard Deviation 55.94
|
—
|
—
|
|
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II
M-II
|
1.5 ng/mL
Standard Deviation 0.88
|
3.7 ng/mL
Standard Deviation 2.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
9.000 hour
Interval 5.92 to 9.03
|
9.000 hour
Interval 1.07 to 9.02
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II
M-I
|
9.030 hour
Interval 9.0 to 9.5
|
9.000 hour
Interval 5.92 to 9.17
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II
M-II
|
9.170 hour
Interval 9.0 to 9.5
|
9.000 hour
Interval 5.92 to 9.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II
TAK-925
|
3.134 hour
Standard Deviation 0.7064
|
3.252 hour
Standard Deviation 0.8597
|
—
|
—
|
|
T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II
M-I
|
2.424 hour
Standard Deviation 0.2989
|
2.490 hour
Standard Deviation 0.3638
|
—
|
—
|
|
T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II
M-II
|
2.235 hour
Standard Deviation 0.6945
|
2.516 hour
Standard Deviation 0.9660
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
CL: Total Clearance After Intravenous Administration for TAK-925
|
46.4 liter per hour (L/h)
Standard Deviation 5.98
|
47.6 liter per hour (L/h)
Standard Deviation 3.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925
|
207.4 liter
Standard Deviation 41.51
|
223.1 liter
Standard Deviation 61.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dosePopulation: The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
|
106.7 liter
Standard Deviation 18.90
|
112.5 liter
Standard Deviation 25.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 14, 10, 6, 2 hours pre-infusion; 2.75, 4.75, 6.75. 8.75 hours post-infusion start; 1.75 hours post-infusion endPopulation: The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.
The KSS scale measures the subjective level of sleepiness at a particular time during the day. On this scale participants indicate which level best reflects the psycho-physical state experienced in the last 10 minutes. The KSS is a 9-item Likert-type rating scale for assessing subjective sleepiness, where 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). Lower score indicates more alertness.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 Participants
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 Participants
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 Participants
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Sleepiness on KSS
6.75 hours post-infusion start
|
8.50 unit on a scale
Standard Error 0.317
|
7.79 unit on a scale
Standard Error 0.336
|
5.18 unit on a scale
Standard Error 0.336
|
5.79 unit on a scale
Standard Error 0.326
|
|
Sleepiness on KSS
8.75 hours post-infusion start
|
8.33 unit on a scale
Standard Error 0.325
|
8.07 unit on a scale
Standard Error 0.340
|
6.07 unit on a scale
Standard Error 0.340
|
6.69 unit on a scale
Standard Error 0.330
|
|
Sleepiness on KSS
1.75 hours post-infusion end
|
8.15 unit on a scale
Standard Error 0.294
|
8.46 unit on a scale
Standard Error 0.312
|
8.01 unit on a scale
Standard Error 0.312
|
7.16 unit on a scale
Standard Error 0.302
|
|
Sleepiness on KSS
14 hours pre-infusion
|
3.05 unit on a scale
Standard Error 0.320
|
2.85 unit on a scale
Standard Error 0.339
|
3.29 unit on a scale
Standard Error 0.339
|
2.79 unit on a scale
Standard Error 0.328
|
|
Sleepiness on KSS
10 hours pre-infusion
|
2.50 unit on a scale
Standard Error 0.283
|
2.79 unit on a scale
Standard Error 0.300
|
2.51 unit on a scale
Standard Error 0.300
|
2.32 unit on a scale
Standard Error 0.291
|
|
Sleepiness on KSS
6 hours pre-infusion
|
2.80 unit on a scale
Standard Error 0.294
|
2.79 unit on a scale
Standard Error 0.312
|
2.51 unit on a scale
Standard Error 0.312
|
2.58 unit on a scale
Standard Error 0.302
|
|
Sleepiness on KSS
2 hours pre-infusion
|
3.90 unit on a scale
Standard Error 0.403
|
4.01 unit on a scale
Standard Error 0.426
|
3.46 unit on a scale
Standard Error 0.426
|
3.32 unit on a scale
Standard Error 0.414
|
|
Sleepiness on KSS
2.75 hours post -infusion start
|
6.85 unit on a scale
Standard Error 0.405
|
4.85 unit on a scale
Standard Error 0.429
|
3.24 unit on a scale
Standard Error 0.429
|
3.69 unit on a scale
Standard Error 0.416
|
|
Sleepiness on KSS
4.75 hours post-infusion start
|
8.15 unit on a scale
Standard Error 0.376
|
6.46 unit on a scale
Standard Error 0.397
|
3.85 unit on a scale
Standard Error 0.397
|
4.32 unit on a scale
Standard Error 0.386
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-925 44 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-925 112 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Modafinil 300 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 44 mg
n=18 participants at risk
TAK-925 44 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
TAK-925 112 mg
n=18 participants at risk
TAK-925 112 mg, intravenously, injection, administered as 9-hour infusion, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
Modafinil 300 mg
n=19 participants at risk
Modafinil 300 mg, tablet, orally, once on Day 1 of Treatment Period 1, 2, 3, or 4.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Discomfort
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling jittery
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling of relaxation
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
3/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 7 days after the last dose of study drug in Treatment Period 4 (Day 1 up to Day 36)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER