Trial Outcomes & Findings for Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia (NCT NCT00606593)
NCT ID: NCT00606593
Last Updated: 2016-03-14
Results Overview
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
2 treatment nights
Results posted on
2016-03-14
Participant Flow
242 subjects were screened at 18 centers in the United States and received single-blind placebo treatment. The first subject screening visit was 12 Dec 2007, the first subject was treated on 19 Dec 2007. 112 subjects were randomized, the first assigned double-blind treatment, was on 26 Dec 2007. Last subject, last clinic visit ended on 4 Apr 2008.
The study consisted of a 2-4-week screening phase on single-blind placebo, a 4-8-week treatment phase, and a 28 day safety follow-up. Subjects were randomized to one of 10 treatment sequences.
Participant milestones
| Measure |
Treatment Sequence 200/100/P/50/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
|
Treatment Sequence 100/50/200/25/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
|
Treatment Sequence 50/25/100/P/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
|
Treatment Sequence 25/P/50/200/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
|
Treatment Sequence P/200/25/100/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
|
Treatment Sequence 25/50/P/100/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
|
Treatment Sequence P/25/200/50/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
|
Treatment Sequence 200/P/100/25/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
|
Treatment Sequence 100/200/50/P/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
|
Treatment Sequence 50/100/25/200/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
12
|
11
|
11
|
11
|
12
|
11
|
|
Overall Study
1st Double-blind Treatment
|
11
|
11
|
11
|
11
|
12
|
11
|
11
|
11
|
12
|
11
|
|
Overall Study
2nd Double-blind Treatment
|
11
|
11
|
11
|
10
|
12
|
11
|
10
|
9
|
12
|
11
|
|
Overall Study
3rd Double-blind Treatment
|
11
|
11
|
10
|
10
|
11
|
11
|
10
|
9
|
12
|
11
|
|
Overall Study
4th Double-blind Treatment
|
10
|
11
|
10
|
10
|
11
|
11
|
10
|
9
|
11
|
11
|
|
Overall Study
5th Double-blind Treatment
|
10
|
11
|
9
|
10
|
11
|
11
|
10
|
9
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
10
|
11
|
11
|
10
|
9
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
1
|
0
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 200/100/P/50/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
|
Treatment Sequence 100/50/200/25/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
|
Treatment Sequence 50/25/100/P/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
|
Treatment Sequence 25/P/50/200/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
|
Treatment Sequence P/200/25/100/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
|
Treatment Sequence 25/50/P/100/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
|
Treatment Sequence P/25/200/50/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
|
Treatment Sequence 200/P/100/25/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
|
Treatment Sequence 100/200/50/P/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
|
Treatment Sequence 50/100/25/200/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal of consent
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative/Other
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Baseline characteristics by cohort
| Measure |
Patient Flow
n=112 Participants
The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
|
|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 treatment nightsPopulation: Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
Outcome measures
| Measure |
Placebo
n=100 Participants
Two capsules containing placebo, orally administered on each of 2 consecutive nights
|
ACT-078573 25 mg
n=100 Participants
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 50 mg
n=100 Participants
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 100 mg
n=100 Participants
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 200 mg
n=100 Participants
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
|
|---|---|---|---|---|---|
|
Mean Wake Time After Sleep Onset (WASO)
|
109.1 minutes
Standard Deviation 36.0
|
98.7 minutes
Standard Deviation 35.5
|
90.0 minutes
Standard Deviation 35.7
|
77.7 minutes
Standard Deviation 33.2
|
62.6 minutes
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: 2 treatment nightsPopulation: Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).
Outcome measures
| Measure |
Placebo
n=100 Participants
Two capsules containing placebo, orally administered on each of 2 consecutive nights
|
ACT-078573 25 mg
n=100 Participants
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 50 mg
n=100 Participants
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 100 mg
n=100 Participants
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 200 mg
n=100 Participants
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
|
|---|---|---|---|---|---|
|
Mean Total Sleep Time (TST)
|
339.7 minutes
Standard Deviation 43.2
|
353.8 minutes
Standard Deviation 40.1
|
360.9 minutes
Standard Deviation 41.7
|
374.2 minutes
Standard Deviation 39.6
|
394.7 minutes
Standard Deviation 34.6
|
Adverse Events
Single-blind Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
ACT-078573 25 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ACT-078573 50 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ACT-078573 100 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ACT-078573 200 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-blind Placebo
n=112 participants at risk
Treatment administered during screening period
|
Placebo
n=107 participants at risk
Two capsules containing placebo, orally administered on each of 2 consecutive nights
|
ACT-078573 25 mg
n=106 participants at risk
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 50 mg
n=106 participants at risk
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 100 mg
n=106 participants at risk
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 200 mg
n=108 participants at risk
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Number of events 1 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
Other adverse events
| Measure |
Single-blind Placebo
n=112 participants at risk
Treatment administered during screening period
|
Placebo
n=107 participants at risk
Two capsules containing placebo, orally administered on each of 2 consecutive nights
|
ACT-078573 25 mg
n=106 participants at risk
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 50 mg
n=106 participants at risk
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 100 mg
n=106 participants at risk
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
|
ACT-078573 200 mg
n=108 participants at risk
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
|
|---|---|---|---|---|---|---|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
3.8%
4/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
1.9%
2/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
1.9%
2/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
HEADACHE
|
1.8%
2/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
1.9%
2/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
2.8%
3/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
1.9%
2/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
General disorders
FATIGUE
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
1.9%
2/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Gastrointestinal disorders
NAUSEA
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
EYE INFECTION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
EYE INFECTION VIRAL
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS SEASONAL
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Nervous system disorders
SEDATION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Renal and urinary disorders
URETHRAL PAIN
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.94%
1/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
General disorders
ASTHENIA
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Injury, poisoning and procedural complications
FALL
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.89%
1/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.00%
0/112 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.93%
1/107 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/106 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
0.00%
0/108 • Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Safety population
|
Additional Information
Pascal Charef/Clinical Trial Leader
Actelion Pharmaceuticals Ltd
Phone: +41 61 565 65 65
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER