Trial Outcomes & Findings for A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED) (NCT NCT00475735)
NCT ID: NCT00475735
Last Updated: 2015-07-28
Results Overview
The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
after 4 weeks of treatment
Results posted on
2015-07-28
Participant Flow
First Patient Dosed: 16 AUG 2007; Last Patient Last Treatment: 04 APR 2008. Six U.S. study centers.
Pre-Treatment consisted of 2 visits: Screening Visit1 \& Baseline Randomization Visit2. Patients continuing after Visit1 entered a 1-wk placebo Run-in period. At Visit2, patients were assessed using the protocol eligibility criteria. Then, if deemed eligible, patients were randomized at Visit2 to one of six 2-period cross-over treatment sequences.
Participant milestones
| Measure |
MK-0249 Then Placebo
These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then MK-0249
These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
|
MK-0249 Then Concerta
These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
|
Concerta Then MK-0249
These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
|
Concerta Then Placebo
These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then Concerta
These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
14
|
13
|
7
|
7
|
16
|
15
|
|
Treatment Period 1
COMPLETED
|
10
|
11
|
7
|
5
|
14
|
12
|
|
Treatment Period 1
NOT COMPLETED
|
4
|
2
|
0
|
2
|
2
|
3
|
|
Treatment Washout
STARTED
|
10
|
12
|
7
|
6
|
16
|
14
|
|
Treatment Washout
COMPLETED
|
10
|
10
|
7
|
6
|
16
|
14
|
|
Treatment Washout
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
10
|
10
|
7
|
6
|
16
|
14
|
|
Treatment Period 2
COMPLETED
|
10
|
9
|
7
|
4
|
15
|
13
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
MK-0249 Then Placebo
These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then MK-0249
These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
|
MK-0249 Then Concerta
These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
|
Concerta Then MK-0249
These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
|
Concerta Then Placebo
These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then Concerta
These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 1
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
DC due to AE but continuing
|
0
|
0
|
0
|
1
|
2
|
2
|
|
Treatment Period 1
DC due to no efficacy but Continuing
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Washout
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Washout
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Treatment Period 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MK-0249 Then Placebo
n=14 Participants
These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then MK-0249
n=13 Participants
These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
|
MK-0249 Then Concerta
n=7 Participants
These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
|
Concerta Then MK-0249
n=7 Participants
These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
|
Concerta Then Placebo
n=16 Participants
These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
|
Placebo Then Concerta
n=15 Participants
These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
36.5 years
STANDARD_DEVIATION 13.3 • n=8 Participants
|
38.4 years
STANDARD_DEVIATION 10.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.
The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
Outcome measures
| Measure |
MK-0249
n=29 Participants
MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
|
Concerta
n=39 Participants
Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
|
Placebo
n=48 Participants
For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
|
|---|---|---|---|
|
Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment
|
-9.8 score on scale
Interval -13.5 to -6.0
|
-15.3 score on scale
Interval -18.7 to -11.8
|
-7.6 score on scale
Interval -10.5 to -4.7
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentThe AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness. Data not reported due to failure of primary hypothesis and program termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 4 weeks of treatmentThe AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. Data not reported due to failure of primary hypothesis and program termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks of treatmentThe Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness. Data not reported due to failure of primary hypothesis and program termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks of treatmentThe Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity. Data not reported due to failure of primary hypothesis and program termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks of treatmentConners' Adult ADHD Rating Scale - Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with "cue" questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90. Data not reported due to failure of primary hypothesis and program termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks of treatmentThe Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness. Data not reported due to failure of primary hypothesis and program termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.
Baseline values for all treatment groups are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134-148).
Outcome measures
| Measure |
MK-0249
n=29 Participants
MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
|
Concerta
n=39 Participants
Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
|
Placebo
n=48 Participants
For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
|
|---|---|---|---|
|
Baseline AISRS
|
34.6 score on scale
Standard Error 2.80
|
34.6 score on scale
Standard Error 2.80
|
34.6 score on scale
Standard Error 2.80
|
Adverse Events
MK-0249
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Concerta
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0249
n=37 participants at risk
MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
|
Concerta
n=44 participants at risk
Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
|
Placebo
n=54 participants at risk
For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
|
|---|---|---|---|
|
General disorders
Irritability
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.5%
2/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Eye disorders
Eye pain
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Eye disorders
Mydriasis
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Eye disorders
Visual disturbance
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
dry mouth
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
22.7%
10/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
5.6%
3/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
nausea
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.5%
2/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
salivary hypersecretion
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
stomach discomfort
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
Chest discomfort
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
Chest pain
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
chills
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
energy increased
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
fatigue
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
9.1%
4/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
5.6%
3/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
feeling hot
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
feeling jittery
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
9.1%
4/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
Influenza like illness
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
pain
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
General disorders
pyrexia
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Infections and infestations
Viral infection
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Injury, poisoning and procedural complications
contusion
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.5%
2/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/36 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/43 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.8%
1/36 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/43 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.8%
1/36 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/43 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.8%
1/36 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.7%
2/43 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/27 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/36 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/43 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Blood pressure increased
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
5.6%
3/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Investigations
Weight decreased
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
9.1%
4/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Metabolism and nutrition disorders
Insulin resistance syndrome
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Head discomfort
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
9.1%
4/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
14.8%
8/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Lethargy
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Paraesthesia
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Somnolence
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Agitation
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
15.9%
7/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Bereavement reaction
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Depressed mood
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
5.6%
3/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Initial insomnia
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Insomnia
|
32.4%
12/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
13.6%
6/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
13.0%
7/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Libido decreased
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Middle insomnia
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Mood altered
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Nightmare
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Restlessness
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Sleep disorder
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Psychiatric disorders
Tic
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Reproductive system and breast disorders
Penile size reduced
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.4%
2/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.5%
2/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
5.6%
3/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.1%
3/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
6.8%
3/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
3.7%
2/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
4.5%
2/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
2.3%
1/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Vascular disorders
Haematoma
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
|
Gastrointestinal disorders
flatulence
|
2.7%
1/37 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
0.00%
0/44 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
1.9%
1/54 • Patients were assessed for AEs from visit 1 Screening through visit 11 End of Week 9
The population for safety analyses was the All Patients as Treated Set (APaTS) population. All patients who were randomized and received at least one dose of study medication were included in the safety analyses. A patient's treatment group was determined by his/her actual treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER