Trial Outcomes & Findings for Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) (NCT NCT01097629)
NCT ID: NCT01097629
Last Updated: 2019-08-28
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
1020 participants
Primary outcome timeframe
Baseline and Month 1
Results posted on
2019-08-28
Participant Flow
A 2-week single-blind placebo Run-in occurred prior to randomization. 1 of the 1020 randomized participants enrolled in 2 separate suvorexant trials and is excluded from all summaries and analyses. 10 other randomized participants were not treated and are in Participant Flow Table below, but are excluded from all other summaries and analyses.
Participant milestones
| Measure |
Suvorexant Low Dose (LD) (TRT 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.
|
Suvorexant High Dose (HD) (TRT 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.
|
Placebo (TRT Phase)
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
|
Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT)
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment (TRT) Phase
STARTED
|
240
|
392
|
387
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Treated
|
239
|
387
|
383
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
COMPLETED
|
205
|
346
|
330
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
NOT COMPLETED
|
35
|
46
|
57
|
0
|
0
|
0
|
0
|
0
|
|
DB RO Phase
STARTED
|
0
|
0
|
0
|
97
|
108
|
173
|
171
|
327
|
|
DB RO Phase
COMPLETED
|
0
|
0
|
0
|
96
|
108
|
172
|
168
|
326
|
|
DB RO Phase
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Suvorexant Low Dose (LD) (TRT 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.
|
Suvorexant High Dose (HD) (TRT 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.
|
Placebo (TRT Phase)
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
|
Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT)
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT)
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT)
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind (DB) Treatment (TRT) Phase
Adverse Event
|
10
|
19
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Withdrawal by Subject
|
8
|
9
|
19
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Protocol Violation
|
5
|
4
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Lost to Follow-up
|
2
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Lack of Efficacy
|
7
|
4
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Physician Decision
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind (DB) Treatment (TRT) Phase
Not Treated
|
1
|
5
|
4
|
0
|
0
|
0
|
0
|
0
|
|
DB RO Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
DB RO Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
DB RO Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)
Baseline characteristics by cohort
| Measure |
Suvorexant LD
n=239 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=387 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 double-blind DB TRT Phase.
|
Total
n=1009 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Wakefulness After Persistent Sleep Onset (WASO)
|
119.6 minutes
STANDARD_DEVIATION 50.8 • n=93 Participants
|
119.4 minutes
STANDARD_DEVIATION 51.3 • n=4 Participants
|
118.4 minutes
STANDARD_DEVIATION 49.1 • n=27 Participants
|
119.0 minutes
STANDARD_DEVIATION 50.3 • n=483 Participants
|
|
Mean Subjective Time to Sleep Onset (sTSOm)
|
86.0 minutes
STANDARD_DEVIATION 77.6 • n=93 Participants
|
74.4 minutes
STANDARD_DEVIATION 61.9 • n=4 Participants
|
81.3 minutes
STANDARD_DEVIATION 76.2 • n=27 Participants
|
79.8 minutes
STANDARD_DEVIATION 71.5 • n=483 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 16 • n=93 Participants
|
57 years
STANDARD_DEVIATION 15 • n=4 Participants
|
57 years
STANDARD_DEVIATION 15 • n=27 Participants
|
56 years
STANDARD_DEVIATION 15 • n=483 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=93 Participants
|
267 Participants
n=4 Participants
|
247 Participants
n=27 Participants
|
671 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
338 Participants
n=483 Participants
|
|
Mean Subjective Total Sleep Time (sTSTm)
|
298.3 minutes
STANDARD_DEVIATION 81.9 • n=93 Participants
|
315.3 minutes
STANDARD_DEVIATION 77.0 • n=4 Participants
|
309.7 minutes
STANDARD_DEVIATION 77.1 • n=27 Participants
|
309.2 minutes
STANDARD_DEVIATION 78.4 • n=483 Participants
|
|
Latency to Onset of Persistent Sleep (LPS)
|
65.3 minutes
STANDARD_DEVIATION 47.8 • n=93 Participants
|
67.3 minutes
STANDARD_DEVIATION 48.8 • n=4 Participants
|
68.0 minutes
STANDARD_DEVIATION 42.8 • n=27 Participants
|
67.2 minutes
STANDARD_DEVIATION 46.2 • 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 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=365 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=350 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1
|
48.7 minutes
95% Confidence Interval 77.4 • Interval 43.1 to 54.3
|
22.4 minutes
95% Confidence Interval 77.6 • Interval 16.7 to 28.1
|
—
|
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 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=340 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=325 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3
|
62.8 minutes
95% Confidence Interval 75.9 • Interval 56.4 to 69.2
|
37.7 minutes
95% Confidence Interval 71.8 • Interval 31.2 to 44.2
|
—
|
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 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=278 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=270 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1
|
-51.9 minutes
95% Confidence Interval 51.2 • Interval -56.9 to -46.9
|
-22.5 minutes
95% Confidence Interval 49.3 • Interval -27.5 to -17.4
|
—
|
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 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=260 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=252 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3
|
-54.2 minutes
95% Confidence Interval 51.1 • Interval -59.3 to -49.1
|
-24.8 minutes
95% Confidence Interval 49.6 • Interval -30.0 to -19.6
|
—
|
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 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=365 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=350 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1
|
-26.9 minutes
95% Confidence Interval 62.8 • Interval -31.1 to -22.8
|
-14.1 minutes
95% Confidence Interval 77.8 • Interval -18.4 to -9.9
|
—
|
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 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=340 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=325 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3
|
-33.7 minutes
95% Confidence Interval 62.4 • Interval -38.0 to -29.3
|
-20.5 minutes
95% Confidence Interval 66.1 • Interval -24.9 to -16.1
|
—
|
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 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=280 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=271 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1
|
-36.7 minutes
95% Confidence Interval 46.5 • Interval -40.8 to -32.7
|
-24.6 minutes
95% Confidence Interval 43.3 • Interval -28.7 to -20.6
|
—
|
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 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=262 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=255 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3
|
-32.2 minutes
95% Confidence Interval 47.6 • Interval -36.7 to -27.7
|
-28.6 minutes
95% Confidence Interval 44.0 • Interval -33.1 to -24.0
|
—
|
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 3-month DB TRT Phase are counted once in this summary.
Outcome measures
| Measure |
Suvorexant HD
n=239 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=387 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase
|
103 participants
|
189 participants
|
167 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 3-month DB TRT Phase are counted once in this summary.
Outcome measures
| Measure |
Suvorexant HD
n=239 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=387 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase
|
9 participants
|
18 participants
|
17 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. The 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; 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=373 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=364 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1
|
40.4 minutes
95% Confidence Interval 83.1 • Interval 35.7 to 45.1
|
14.0 minutes
95% Confidence Interval 81.0 • Interval 9.2 to 18.7
|
—
|
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. The 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=285 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=283 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1
|
-63.3 minutes
95% Confidence Interval 37.5 • Interval -68.0 to -58.6
|
-21.3 minutes
95% Confidence Interval 65.5 • Interval -26.1 to -16.6
|
—
|
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. The 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; 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=373 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=364 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1
|
-19.7 minutes
95% Confidence Interval 59.0 • Interval -23.0 to -16.4
|
-6.7 minutes
95% Confidence Interval 76.0 • Interval -10.0 to -3.3
|
—
|
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. The 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=289 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=284 Participants
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind 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 double-blind DB TRT Phase.
|
|---|---|---|---|
|
Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1
|
-34.7 minutes
95% Confidence Interval 24.2 • Interval -39.5 to -29.9
|
-13.0 minutes
95% Confidence Interval 60.8 • Interval -17.8 to -8.1
|
—
|
Adverse Events
Suvorexant LD (TRT Phase)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Suvorexant HD (TRT Phase)
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo (TRT Phase)
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Suvorexant LD (RO, After Suvorexant LD in TRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant LD in TRT)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Suvorexant HD (RO, After Suvorexant HD in TRT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant HD in TRT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (RO, After Placebo in TRT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Suvorexant LD (TRT Phase): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suvorexant HD (TRT Phase): Follow-up
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (TRT Phase): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant LD in TRT): Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Suvorexant HD in TRT): Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (RO, After Placebo in TRT): Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant LD (TRT Phase)
n=239 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=387 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=383 participants at risk
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT)
n=97 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT)
n=108 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT)
n=173 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT)
n=171 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT)
n=327 participants at risk
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant LD (TRT Phase): Follow-up
n=239 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
|
Suvorexant HD (TRT Phase): Follow-up
n=387 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
|
Placebo (TRT 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 Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up
n=97 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 and RO Phases.
|
Placebo (RO, After Suvorexant LD in TRT): Follow-up
n=108 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 Phase and placebo during RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up
n=173 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 and RO Phases.
|
Placebo (RO, After Suvorexant HD in TRT): Follow-up
n=171 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 Phase and placebo during RO Phase.
|
Placebo (RO, After Placebo in TRT): 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 and RO Phases.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.42%
1/239 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Endocrine disorders
autoimmune thyroiditis
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Infections and infestations
endometritis
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Infections and infestations
meningitis
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.93%
1/108 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.42%
1/239 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Injury, poisoning and procedural complications
compression fracture
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Injury, poisoning and procedural complications
ulna fracture
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder neoplasm
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant melanoma
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Nervous system disorders
hypoxic-ischaemic encephalopathy
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Psychiatric disorders
alcohol withdrawal syndrome
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.26%
1/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
Other adverse events
| Measure |
Suvorexant LD (TRT Phase)
n=239 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=387 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=383 participants at risk
After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT)
n=97 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant LD in TRT)
n=108 participants at risk
After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT)
n=173 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Suvorexant HD in TRT)
n=171 participants at risk
After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Placebo (RO, After Placebo in TRT)
n=327 participants at risk
After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
|
Suvorexant LD (TRT Phase): Follow-up
n=239 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
|
Suvorexant HD (TRT Phase): Follow-up
n=387 participants at risk
During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
|
Placebo (TRT 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 Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
|
Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up
n=97 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 and RO Phases.
|
Placebo (RO, After Suvorexant LD in TRT): Follow-up
n=108 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 Phase and placebo during RO Phase.
|
Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up
n=173 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 and RO Phases.
|
Placebo (RO, After Suvorexant HD in TRT): Follow-up
n=171 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 Phase and placebo during RO Phase.
|
Placebo (RO, After Placebo in TRT): 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 and RO Phases.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
7.9%
19/239 • Number of events 22 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
7.5%
29/387 • Number of events 32 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
5.7%
22/383 • Number of events 22 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.93%
1/108 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
1.7%
3/173 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.58%
1/171 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
1.2%
4/327 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.52%
2/387 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.93%
1/108 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
|
Nervous system disorders
somnolence
|
8.4%
20/239 • Number of events 21 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
10.3%
40/387 • Number of events 44 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
3.1%
12/383 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.58%
1/173 • 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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/239 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/387 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/97 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/108 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/173 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
0.00%
0/171 • Up to 14 days after the last dose of study drug
The 3 TRT Phase reporting groups include total population; other groups present same or subsets of this population in other study phases. Events are reported by phase. Phases are: - TRT - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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 - RO - Follow-up (enter directly from TRT Phase, or from RO)
|
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