Trial Outcomes & Findings for Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028) (NCT NCT01097616)
NCT ID: NCT01097616
Last Updated: 2018-09-21
Results Overview
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography \[PSG\] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1023 participants
Primary outcome timeframe
Baseline and Month 1
Results posted on
2018-09-21
Participant Flow
A 2-week single-blind placebo Run-in occurred prior to randomization. 1 of the 1023 randomized participants enrolled in 2 separate suvorexant trials and is excluded from all summaries and analyses. 1 other randomized participant was not treated and is in Participant Flow Table below, but is excluded from all other summaries and analyses.
Participant milestones
| Measure |
Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)
After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to \<65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
|
Suvorexant High Dose (HD) (TRT/EXT Phase)
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
|
Placebo (TRT/EXT Phase)
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
|
Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT/EXT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT/EXT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT)
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment (TRT) Phase
STARTED
|
254
|
383
|
385
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Treated
|
254
|
383
|
384
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
COMPLETED
|
230
|
345
|
341
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
NOT COMPLETED
|
24
|
38
|
44
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
STARTED
|
100
|
172
|
151
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
COMPLETED
|
85
|
151
|
141
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
NOT COMPLETED
|
15
|
21
|
10
|
0
|
0
|
0
|
0
|
0
|
|
DB RO Phase
STARTED
|
0
|
0
|
0
|
101
|
112
|
161
|
162
|
327
|
|
DB RO Phase
COMPLETED
|
0
|
0
|
0
|
100
|
111
|
159
|
161
|
326
|
|
DB RO Phase
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)
After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to \<65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
|
Suvorexant High Dose (HD) (TRT/EXT Phase)
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
|
Placebo (TRT/EXT Phase)
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
|
Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT/EXT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT/EXT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT)
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment (TRT) Phase
Adverse Event
|
6
|
15
|
21
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Withdrawal by Subject
|
6
|
8
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Protocol Violation
|
5
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Lack of Efficacy
|
1
|
7
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Pregnancy
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Physician Decision
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Not Treated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Adverse Event
|
0
|
7
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Withdrawal by Subject
|
12
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Protocol Violation
|
0
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Lost to Follow-up
|
1
|
5
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Lack of Efficacy
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Optional DB EXT Phase
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB RO Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
DB RO Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
DB RO Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
DB RO Phase
Not Treated in RO
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Baseline characteristics by cohort
| Measure |
Suvorexant LD
n=254 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to \<65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Suvorexant HD
n=383 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=384 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Total
n=1021 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 16 • n=113 Participants
|
56 years
STANDARD_DEVIATION 15 • n=163 Participants
|
56 years
STANDARD_DEVIATION 15 • n=160 Participants
|
56 years
STANDARD_DEVIATION 15 • n=483 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=113 Participants
|
230 Participants
n=163 Participants
|
245 Participants
n=160 Participants
|
637 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=113 Participants
|
153 Participants
n=163 Participants
|
139 Participants
n=160 Participants
|
384 Participants
n=483 Participants
|
|
Mean Subjective Total Sleep Time (sTSTm)
|
322.4 minutes
STANDARD_DEVIATION 57.3 • n=113 Participants
|
316.1 minutes
STANDARD_DEVIATION 67.2 • n=163 Participants
|
315.7 minutes
STANDARD_DEVIATION 65.1 • n=160 Participants
|
317.5 minutes
STANDARD_DEVIATION 64.1 • n=483 Participants
|
|
Wakefulness After Persistent Sleep Onset (WASO)
|
119.2 minutes
STANDARD_DEVIATION 46.5 • n=113 Participants
|
117.7 minutes
STANDARD_DEVIATION 49.6 • n=163 Participants
|
114.9 minutes
STANDARD_DEVIATION 45.7 • n=160 Participants
|
117.0 minutes
STANDARD_DEVIATION 47.4 • n=483 Participants
|
|
Mean Subjective Time to Sleep Onset (sTSOm)
|
63.3 minutes
STANDARD_DEVIATION 37.1 • n=113 Participants
|
68.0 minutes
STANDARD_DEVIATION 50.1 • n=163 Participants
|
66.9 minutes
STANDARD_DEVIATION 40.5 • n=160 Participants
|
66.4 minutes
STANDARD_DEVIATION 43.6 • n=483 Participants
|
|
Latency to Onset of Persistent Sleep (LPS)
|
68.9 minutes
STANDARD_DEVIATION 49.7 • n=113 Participants
|
61.8 minutes
STANDARD_DEVIATION 39.1 • n=163 Participants
|
66.2 minutes
STANDARD_DEVIATION 44.1 • n=160 Participants
|
65.2 minutes
STANDARD_DEVIATION 43.8 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography \[PSG\] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=363 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=365 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1
|
42.6 minutes
Interval 37.3 to 48.0
|
23.1 minutes
Interval 17.7 to 28.4
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=348 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=339 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3
|
60.3 minutes
Interval 54.8 to 65.8
|
40.6 minutes
Interval 35.0 to 46.1
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=272 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=272 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1
|
-45.0 minutes
Interval -50.1 to -39.9
|
-18.7 minutes
Interval -23.7 to -13.6
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=251 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=251 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3
|
-47.9 minutes
Interval -53.2 to -42.6
|
-25.0 minutes
Interval -30.3 to -19.8
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=363 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=365 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1
|
-19.1 minutes
Interval -22.6 to -15.7
|
-11.7 minutes
Interval -15.2 to -8.2
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=348 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=339 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3
|
-25.7 minutes
Interval -28.8 to -22.6
|
-17.3 minutes
Interval -20.4 to -14.2
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=275 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=272 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1
|
-34.5 minutes
Interval -38.1 to -30.9
|
-23.3 minutes
Interval -26.9 to -19.7
|
—
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=254 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=251 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3
|
-36.0 minutes
Interval -39.7 to -32.4
|
-26.6 minutes
Interval -30.2 to -22.9
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
Outcome measures
| Measure |
Suvorexant HD
n=254 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=383 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=384 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase
|
126 participants
|
198 participants
|
191 participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
Outcome measures
| Measure |
Suvorexant HD
n=254 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=383 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=384 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase
|
6 participants
|
18 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=248 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=379 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=376 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1
|
28.2 minutes
Interval 23.0 to 33.4
|
36.0 minutes
Interval 31.8 to 40.2
|
14.6 minutes
Interval 10.4 to 18.8
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=244 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=365 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1
|
39.4 minutes
Interval 32.8 to 45.9
|
23.1 minutes
Interval 17.7 to 28.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=228 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=339 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3
|
51.2 minutes
Interval 44.4 to 58.1
|
40.6 minutes
Interval 35.0 to 46.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Night 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=192 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=291 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=287 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1
|
-52.1 minutes
Interval -57.4 to -46.8
|
-58.0 minutes
Interval -62.3 to -53.7
|
-19.6 minutes
Interval -23.9 to -15.3
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=185 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=272 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1
|
-45.0 minutes
Interval -51.2 to -38.9
|
-18.7 minutes
Interval -23.7 to -13.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=172 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=251 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3
|
-41.6 minutes
Interval -48.0 to -35.2
|
-25.0 minutes
Interval -30.3 to -19.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=248 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=379 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=376 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1
|
-15.2 minutes
Interval -18.7 to -11.7
|
-15.3 minutes
Interval -18.1 to -12.4
|
-9.6 minutes
Interval -12.5 to -6.7
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=244 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=365 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1
|
-17.1 minutes
Interval -21.4 to -12.9
|
-11.7 minutes
Interval -15.2 to -8.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Outcome measures
| Measure |
Suvorexant HD
n=228 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=339 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3
|
-22.5 minutes
Interval -26.3 to -18.7
|
-17.3 minutes
Interval -20.4 to -14.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Night 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=193 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=291 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=290 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1
|
-29.9 minutes
Interval -34.0 to -25.8
|
-30.6 minutes
Interval -33.9 to -27.2
|
-20.3 minutes
Interval -23.6 to -17.0
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=185 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=272 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1
|
-33.6 minutes
Interval -37.9 to -29.2
|
-23.3 minutes
Interval -26.9 to -19.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Outcome measures
| Measure |
Suvorexant HD
n=172 Participants
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
n=251 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Placebo
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3
|
-34.7 minutes
Interval -39.1 to -30.2
|
-26.6 minutes
Interval -30.2 to -22.9
|
—
|
Adverse Events
Suvorexant LD (TRT Phase)
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Suvorexant HD (TRT Phase)
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo (TRT Phase)
Serious events: 11 serious events
Other events: 67 other events
Deaths: 0 deaths
Suvorexant LD (EXT Phase)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Suvorexant HD (EXT Phase)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo (EXT Phase)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant LD in TRT/EXT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant HD in TRT/EXT)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (RO, After Placebo in TRT/EXT)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Suvorexant LD (TRT/EXT Phase): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suvorexant HD (TRT/EXT Phase): Follow-up
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (TRT/EXT Phase): Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (RO, After Placebo in TRT/EXT): Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant LD (TRT Phase)
n=254 participants at risk
After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to \<65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Suvorexant HD (TRT Phase)
n=383 participants at risk
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo (TRT Phase)
n=384 participants at risk
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Suvorexant LD (EXT Phase)
n=100 participants at risk
After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
|
Suvorexant HD (EXT Phase)
n=172 participants at risk
After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
|
Placebo (EXT Phase)
n=151 participants at risk
After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)
n=102 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT/EXT)
n=111 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)
n=160 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT/EXT)
n=162 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT)
n=327 participants at risk
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant LD (TRT/EXT Phase): Follow-up
n=254 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
|
Suvorexant HD (TRT/EXT Phase): Follow-up
n=383 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
|
Placebo (TRT/EXT Phase): Follow-up
n=384 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up
n=102 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
|
Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up
n=111 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up
n=160 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
|
Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up
n=162 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT): Follow-up
n=327 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
tibia fracture
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.62%
1/162 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Gastrointestinal disorders
duodenal ulcer
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.58%
1/172 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Infections and infestations
pneumonia
|
0.39%
1/254 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.52%
2/384 • Number of events 2 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Injury, poisoning and procedural complications
fibula fracture
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 5 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.58%
1/172 • Number of events 2 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
borderline ovarian tumor
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Nervous system disorders
subarachnoid haemorrage
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.58%
1/172 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/383 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/100 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/172 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/151 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
Other adverse events
| Measure |
Suvorexant LD (TRT Phase)
n=254 participants at risk
After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to \<65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Suvorexant HD (TRT Phase)
n=383 participants at risk
After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
|
Placebo (TRT Phase)
n=384 participants at risk
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
|
Suvorexant LD (EXT Phase)
n=100 participants at risk
After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
|
Suvorexant HD (EXT Phase)
n=172 participants at risk
After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
|
Placebo (EXT Phase)
n=151 participants at risk
After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)
n=102 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT/EXT)
n=111 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)
n=160 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT/EXT)
n=162 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT)
n=327 participants at risk
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant LD (TRT/EXT Phase): Follow-up
n=254 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
|
Suvorexant HD (TRT/EXT Phase): Follow-up
n=383 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
|
Placebo (TRT/EXT Phase): Follow-up
n=384 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up
n=102 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
|
Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up
n=111 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up
n=160 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
|
Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up
n=162 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
|
Placebo (RO, After Placebo in TRT/EXT): Follow-up
n=327 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
nasopharnygitis
|
7.1%
18/254 • Number of events 18 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
8.4%
32/383 • Number of events 33 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
8.9%
34/384 • Number of events 35 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
4.0%
4/100 • Number of events 4 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
5.2%
9/172 • Number of events 10 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.66%
1/151 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.98%
1/102 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.62%
1/162 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.31%
1/327 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.62%
1/162 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.61%
2/327 • Number of events 2 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Nervous system disorders
headache
|
6.7%
17/254 • Number of events 19 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
6.8%
26/383 • Number of events 33 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
6.0%
23/384 • Number of events 28 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
1.0%
1/100 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
1.2%
2/172 • Number of events 4 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.66%
1/151 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.62%
1/162 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.61%
2/327 • Number of events 2 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/383 • Number of events 3 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.26%
1/384 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.62%
1/160 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
|
Nervous system disorders
somnolence
|
5.1%
13/254 • Number of events 14 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
10.7%
41/383 • Number of events 41 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
3.4%
13/384 • Number of events 13 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
1.0%
1/100 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
1.7%
3/172 • Number of events 3 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.66%
1/151 • Number of events 1 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/254 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/383 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/384 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/102 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/111 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/160 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/162 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
0.00%
0/327 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - EXT - RO (enter from TRT or EXT phase) - Follow-up (enter directly from TRT or EXT Phase, or from RO). Participants are allocated to treatment actually received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may publish results for his/her study site after publication of results of entire multicenter trial, or after public disclosure of the results online if a multicenter manuscript is not planned. Sponsor must be able to review all proposed results communications regarding study 60 days prior to submission for publication/presentation. Information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER