Trial Outcomes & Findings for Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort (NCT NCT01700959)
NCT ID: NCT01700959
Last Updated: 2018-06-28
Results Overview
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
911 participants
Primary outcome timeframe
Baseline and 6 months after start of therapy
Results posted on
2018-06-28
Participant Flow
911 participants were enrolled and screened between February 2013 and June 2017. Of the 911, 298 were ineligible and 33 withdrew prior to randomization. 580 were randomized.
The remaining 580 participants were categorized into three mutually exclusive groups: (1) neurocognitive impairment (NI) without delayed sleep onset latency (DSOL), (2) NI with DSOL, and (3) No NI with DSOL. Participants were then randomized to take melatonin or placebo.
Participant milestones
| Measure |
Melatonin: NI Without DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
88
|
105
|
105
|
96
|
97
|
|
Overall Study
COMPLETED
|
62
|
64
|
65
|
70
|
69
|
72
|
|
Overall Study
NOT COMPLETED
|
27
|
24
|
40
|
35
|
27
|
25
|
Reasons for withdrawal
| Measure |
Melatonin: NI Without DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
9
|
12
|
11
|
8
|
12
|
|
Overall Study
Ineligible
|
2
|
1
|
2
|
0
|
0
|
1
|
|
Overall Study
Noncompliant
|
9
|
9
|
17
|
18
|
15
|
9
|
|
Overall Study
Side effects
|
1
|
4
|
8
|
4
|
4
|
1
|
Baseline Characteristics
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Baseline characteristics by cohort
| Measure |
Melatonin: NI Without DSOL
n=58 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
n=58 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
n=62 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
n=68 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
n=66 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
n=68 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
347 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
338 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
35.8 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
36.5 years
STANDARD_DEVIATION 8.2 • n=8 Participants
|
34.46 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
207 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
173 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 months after start of therapyPopulation: Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Outcome measures
| Measure |
Melatonin: NI Without DSOL
n=58 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
n=58 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
n=62 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
n=68 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Auditory Attention Difference
|
0.35 Z-score
Standard Deviation 1.02
|
0.18 Z-score
Standard Deviation 0.87
|
0.06 Z-score
Standard Deviation 1.11
|
0.37 Z-score
Standard Deviation 0.96
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Sustained Attention Difference
|
0.06 Z-score
Standard Deviation 1.11
|
0.16 Z-score
Standard Deviation 1.30
|
0.24 Z-score
Standard Deviation 1.16
|
0.08 Z-score
Standard Deviation 1.39
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Working Memory Difference
|
0.17 Z-score
Standard Deviation 0.67
|
0.07 Z-score
Standard Deviation 0.82
|
0.03 Z-score
Standard Deviation 0.75
|
0.004 Z-score
Standard Deviation 0.76
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Long-term Verbal Memory Difference
|
0.02 Z-score
Standard Deviation 1.16
|
-0.03 Z-score
Standard Deviation 1.04
|
-0.13 Z-score
Standard Deviation 0.98
|
-0.15 Z-score
Standard Deviation 1.29
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Cognitive Flexibility
|
0.31 Z-score
Standard Deviation 1.22
|
0.31 Z-score
Standard Deviation 1.060
|
0.31 Z-score
Standard Deviation 1.37
|
0.18 Z-score
Standard Deviation 1.19
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Cognitive Fluency Difference
|
0.14 Z-score
Standard Deviation 0.68
|
0.21 Z-score
Standard Deviation 0.74
|
0.16 Z-score
Standard Deviation 0.64
|
0.18 Z-score
Standard Deviation 0.63
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and six months after start of therapyPopulation: Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.
Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.
Outcome measures
| Measure |
Melatonin: NI Without DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
n=62 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
n=68 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
n=66 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
n=68 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Sleep Onset Latency as Measured by Actigraphy and Self-report.
Sleep onset latency - actigraphy
|
—
|
—
|
5.66 minutes
Standard Deviation 29.70
|
-10.96 minutes
Standard Deviation 30.21
|
-8.47 minutes
Standard Deviation 23.95
|
1.95 minutes
Standard Deviation 39.71
|
|
Sleep Onset Latency as Measured by Actigraphy and Self-report.
Sleet onset latency - self-report
|
—
|
—
|
-20.59 minutes
Standard Deviation 23.73
|
17.79 minutes
Standard Deviation 37.19
|
-18.14 minutes
Standard Deviation 27.06
|
-29.03 minutes
Standard Deviation 64.49
|
SECONDARY outcome
Timeframe: Baseline and six months after start of therapyPopulation: Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.
Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.
Outcome measures
| Measure |
Melatonin: NI Without DSOL
n=50 Participants
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
n=62 Participants
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Auditory Attention Difference
|
0.22 Z-score
|
-0.09 Z-score
|
—
|
—
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Sustained Attention Difference
|
-0.10 Z-score
|
-0.16 Z-score
|
—
|
—
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Working Memory Difference
|
0.04 Z-score
|
-0.001 Z-score
|
—
|
—
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Long-term Verbal Memory Difference
|
0.07 Z-score
|
-0.02 Z-score
|
—
|
—
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Cognitive Flexibility
|
0.30 Z-score
|
0.15 Z-score
|
—
|
—
|
—
|
—
|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Cognitive Fluency Difference
|
-0.22 Z-score
|
0.03 Z-score
|
—
|
—
|
—
|
—
|
Adverse Events
Melatonin: NI Without DSOL
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo: NI Without DSOL
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Melatonin: NI With DSOL
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo: NI With DSOL
Serious events: 6 serious events
Other events: 60 other events
Deaths: 0 deaths
Melatonin: No NI With DSOL
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo: No NI With DSOL
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melatonin: NI Without DSOL
n=58 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
n=58 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
n=62 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
n=68 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
n=66 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
n=68 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Eye disorders
Blurred vision
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Gallstones
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
General disorders
Fatigue
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical cancer
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Trabecular cancer in lungs
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parotid tumor
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/66 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Headache
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/66 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.4%
3/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Concentration impairment
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptoms
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Surgical and medical procedures
Esophageal dilation
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
Other adverse events
| Measure |
Melatonin: NI Without DSOL
n=58 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI Without DSOL
n=58 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: NI With DSOL
n=62 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: NI With DSOL
n=68 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
Melatonin: No NI With DSOL
n=66 participants at risk
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months.
melatonin: Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
|
Placebo: No NI With DSOL
n=68 participants at risk
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months.
placebo: Placebo tablets to match the melatonin will be comprised of inert substances.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitation
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.4%
3/68 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.0%
2/66 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.8%
8/68 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.5%
3/66 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.7%
10/68 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Cardiac disorders
Chest pain
|
6.9%
4/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.8%
3/62 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.4%
5/68 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
6.1%
4/66 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.4%
3/68 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.9%
4/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
12.1%
7/58 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.5%
3/66 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.4%
5/68 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Eye disorders
Blurred vision
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
9.1%
6/66 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.8%
8/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
4/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.1%
10/62 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.2%
9/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
9.1%
6/66 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Diarrhea
|
12.1%
7/58 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
12.1%
7/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.1%
10/62 • Number of events 14 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.2%
11/68 • Number of events 13 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
21.2%
14/66 • Number of events 25 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
25.0%
17/68 • Number of events 20 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.8%
8/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
6.5%
4/62 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
7/68 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.6%
7/66 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
19.1%
13/68 • Number of events 15 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/62 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/66 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
General disorders
Dry mouth
|
10.3%
6/58 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.5%
9/62 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.7%
10/68 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.6%
9/66 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.2%
11/68 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
General disorders
Fatigue
|
17.2%
10/58 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
22.4%
13/58 • Number of events 20 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
33.9%
21/62 • Number of events 26 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
36.8%
25/68 • Number of events 27 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
31.8%
21/66 • Number of events 23 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
42.6%
29/68 • Number of events 37 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
General disorders
Malaise
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.1%
5/62 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.5%
3/66 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
7/68 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
6.5%
4/62 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.0%
2/66 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.4%
3/68 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Dizziness
|
10.3%
6/58 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
25.8%
16/62 • Number of events 20 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.7%
10/68 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
18.2%
12/66 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
17.6%
12/68 • Number of events 14 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Headache
|
25.9%
15/58 • Number of events 20 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
31.0%
18/58 • Number of events 27 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
37.1%
23/62 • Number of events 32 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
39.7%
27/68 • Number of events 32 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
39.4%
26/66 • Number of events 37 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
39.7%
27/68 • Number of events 35 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Hypersomnia
|
10.3%
6/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
19.4%
12/62 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
17.6%
12/68 • Number of events 14 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
12.1%
8/66 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.8%
8/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Nightmares
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.6%
5/58 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.8%
3/62 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
9.1%
6/66 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.8%
8/68 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Pain
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.0%
2/66 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.4%
3/68 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Nervous system disorders
Somnolence
|
32.8%
19/58 • Number of events 21 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
25.9%
15/58 • Number of events 18 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
37.1%
23/62 • Number of events 24 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
30.9%
21/68 • Number of events 25 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
37.9%
25/66 • Number of events 34 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
42.6%
29/68 • Number of events 36 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Anxiety
|
8.6%
5/58 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.1%
10/62 • Number of events 12 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.2%
11/68 • Number of events 17 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
15.2%
10/66 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
29.4%
20/68 • Number of events 21 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Delayed orgasm
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/66 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Incomnia
|
19.0%
11/58 • Number of events 16 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
19.0%
11/58 • Number of events 14 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
22.6%
14/62 • Number of events 15 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
29.4%
20/68 • Number of events 21 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
39.4%
26/66 • Number of events 38 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
35.3%
24/68 • Number of events 35 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Libido decreased
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.6%
5/58 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
2.9%
2/68 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.6%
5/66 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.2%
9/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Restlessness
|
6.9%
4/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.3%
7/62 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.2%
11/68 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.6%
9/66 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
17.6%
12/68 • Number of events 13 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Renal and urinary disorders
Urinary frequency
|
12.1%
7/58 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.5%
9/62 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.2%
9/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.6%
7/66 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.0%
2/66 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.5%
1/68 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
6.5%
4/62 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.6%
5/66 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/58 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/58 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
1.6%
1/62 • Number of events 1 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/66 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
0.00%
0/68 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.8%
8/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.8%
8/58 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
19.4%
12/62 • Number of events 13 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.7%
10/68 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
12.1%
8/66 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
16.2%
11/68 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
10.3%
6/58 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
8.8%
6/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
4.5%
3/66 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.4%
5/68 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.5%
9/58 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
12.1%
7/58 • Number of events 8 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
9.7%
6/62 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.7%
10/68 • Number of events 10 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
15.2%
10/66 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
13.2%
9/68 • Number of events 11 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Skin and subcutaneous tissue disorders
Maculo=papular rash
|
6.9%
4/58 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.2%
3/58 • Number of events 3 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
3.2%
2/62 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
11.8%
8/68 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
9.1%
6/66 • Number of events 7 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
5.9%
4/68 • Number of events 4 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
|
Psychiatric disorders
Concentration impairment
|
3.4%
2/58 • Number of events 2 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
6.9%
4/58 • Number of events 6 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
14.5%
9/62 • Number of events 9 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
20.6%
14/68 • Number of events 17 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
7.6%
5/66 • Number of events 5 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
19.1%
13/68 • Number of events 13 • Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
|
Additional Information
Tara M. Brinkman, PhD
St. Jude Children's Research Hospital
Phone: (901) 595-5683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place