Trial Outcomes & Findings for Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder (NCT NCT00730691)
NCT ID: NCT00730691
Last Updated: 2013-12-18
Results Overview
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
781 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2013-12-18
Participant Flow
Participants took part in the study at 71 investigative sites in the United States from 20 June 2008 to 27 February 2009.
Participants with a diagnosis of generalized anxiety disorder were enrolled equally in 1 of 5 treatment groups, once a day placebo, 2.5 mg, 5 mg or 10 mg vortioxetine, or 60 mg duloxetine.
Participant milestones
| Measure |
Placebo
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
157
|
156
|
156
|
156
|
156
|
|
Overall Study
COMPLETED
|
121
|
120
|
117
|
111
|
106
|
|
Overall Study
NOT COMPLETED
|
36
|
36
|
39
|
45
|
50
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
8
|
11
|
11
|
23
|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
2
|
1
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
6
|
1
|
6
|
3
|
3
|
|
Overall Study
Protocol Deviations
|
3
|
5
|
3
|
7
|
5
|
|
Overall Study
Withdrawal of Consent
|
7
|
9
|
3
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
13
|
15
|
13
|
|
Overall Study
Other
|
1
|
1
|
1
|
2
|
2
|
Baseline Characteristics
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=157 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=156 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=156 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=156 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=156 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
Total
n=781 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
36.8 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 11.90 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 12.33 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 12.28 • n=21 Participants
|
38.6 years
STANDARD_DEVIATION 12.14 • n=10 Participants
|
|
Age, Customized
≤55 years
|
143 participants
n=5 Participants
|
140 participants
n=7 Participants
|
147 participants
n=5 Participants
|
137 participants
n=4 Participants
|
137 participants
n=21 Participants
|
704 participants
n=10 Participants
|
|
Age, Customized
>55 years
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
19 participants
n=4 Participants
|
19 participants
n=21 Participants
|
77 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
529 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
252 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Caucasian (White, including Hispanic)
|
118 participants
n=5 Participants
|
121 participants
n=7 Participants
|
124 participants
n=5 Participants
|
120 participants
n=4 Participants
|
121 participants
n=21 Participants
|
604 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
35 participants
n=5 Participants
|
31 participants
n=7 Participants
|
26 participants
n=5 Participants
|
33 participants
n=4 Participants
|
31 participants
n=21 Participants
|
156 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
14 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
157 participants
n=5 Participants
|
156 participants
n=7 Participants
|
156 participants
n=5 Participants
|
156 participants
n=4 Participants
|
156 participants
n=21 Participants
|
781 participants
n=10 Participants
|
|
Weight
|
84.40 kg
STANDARD_DEVIATION 25.426 • n=5 Participants
|
79.47 kg
STANDARD_DEVIATION 19.893 • n=7 Participants
|
80.98 kg
STANDARD_DEVIATION 20.312 • n=5 Participants
|
80.17 kg
STANDARD_DEVIATION 21.420 • n=4 Participants
|
79.51 kg
STANDARD_DEVIATION 20.090 • n=21 Participants
|
80.91 kg
STANDARD_DEVIATION 21.558 • n=10 Participants
|
|
Height
|
168.74 cm
STANDARD_DEVIATION 9.605 • n=5 Participants
|
167.87 cm
STANDARD_DEVIATION 9.139 • n=7 Participants
|
169.25 cm
STANDARD_DEVIATION 9.282 • n=5 Participants
|
167.61 cm
STANDARD_DEVIATION 8.378 • n=4 Participants
|
167.94 cm
STANDARD_DEVIATION 9.300 • n=21 Participants
|
168.28 cm
STANDARD_DEVIATION 9.147 • n=10 Participants
|
|
Body Mass Index (BMI)
|
29.54 kg/m^2
STANDARD_DEVIATION 8.478 • n=5 Participants
|
28.19 kg/m^2
STANDARD_DEVIATION 6.651 • n=7 Participants
|
28.24 kg/m^2
STANDARD_DEVIATION 6.589 • n=5 Participants
|
28.49 kg/m^2
STANDARD_DEVIATION 7.058 • n=4 Participants
|
28.10 kg/m^2
STANDARD_DEVIATION 6.325 • n=21 Participants
|
28.51 kg/m^2
STANDARD_DEVIATION 7.064 • n=10 Participants
|
|
Smoking Classification
Never Smoked
|
92 participants
n=5 Participants
|
85 participants
n=7 Participants
|
81 participants
n=5 Participants
|
85 participants
n=4 Participants
|
82 participants
n=21 Participants
|
425 participants
n=10 Participants
|
|
Smoking Classification
Current Smoker
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
44 participants
n=5 Participants
|
43 participants
n=4 Participants
|
43 participants
n=21 Participants
|
214 participants
n=10 Participants
|
|
Smoking Classification
Ex-smoker
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
31 participants
n=5 Participants
|
28 participants
n=4 Participants
|
31 participants
n=21 Participants
|
141 participants
n=10 Participants
|
|
Alcohol Consumption
Never
|
40 participants
n=5 Participants
|
49 participants
n=7 Participants
|
40 participants
n=5 Participants
|
53 participants
n=4 Participants
|
44 participants
n=21 Participants
|
226 participants
n=10 Participants
|
|
Alcohol Consumption
Once monthly or less often
|
71 participants
n=5 Participants
|
50 participants
n=7 Participants
|
66 participants
n=5 Participants
|
49 participants
n=4 Participants
|
64 participants
n=21 Participants
|
300 participants
n=10 Participants
|
|
Alcohol Consumption
Once a week
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
31 participants
n=5 Participants
|
29 participants
n=4 Participants
|
19 participants
n=21 Participants
|
131 participants
n=10 Participants
|
|
Alcohol Consumption
2 to 6 times per week
|
17 participants
n=5 Participants
|
30 participants
n=7 Participants
|
17 participants
n=5 Participants
|
22 participants
n=4 Participants
|
22 participants
n=21 Participants
|
108 participants
n=10 Participants
|
|
Alcohol Consumption
Daily
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
15 participants
n=10 Participants
|
|
Hamilton Anxiety Scale Total Score
|
24.4 scores on a scale
STANDARD_DEVIATION 3.73 • n=5 Participants
|
25.3 scores on a scale
STANDARD_DEVIATION 4.25 • n=7 Participants
|
25.0 scores on a scale
STANDARD_DEVIATION 3.57 • n=5 Participants
|
25.3 scores on a scale
STANDARD_DEVIATION 3.96 • n=4 Participants
|
25.0 scores on a scale
STANDARD_DEVIATION 3.94 • n=21 Participants
|
25.0 scores on a scale
STANDARD_DEVIATION 3.90 • n=10 Participants
|
|
Clinical Global Impression - Severity scale score
|
4.3 scores on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 0.63 • n=7 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 0.59 • n=4 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 0.62 • n=21 Participants
|
4.4 scores on a scale
STANDARD_DEVIATION 0.60 • n=10 Participants
|
|
Hospital Anxiety and Depression - Anxiety subscale
|
13.9 scores on a scale
STANDARD_DEVIATION 3.23 • n=5 Participants
|
13.8 scores on a scale
STANDARD_DEVIATION 3.40 • n=7 Participants
|
13.8 scores on a scale
STANDARD_DEVIATION 3.70 • n=5 Participants
|
14.0 scores on a scale
STANDARD_DEVIATION 3.02 • n=4 Participants
|
13.4 scores on a scale
STANDARD_DEVIATION 3.70 • n=21 Participants
|
13.8 scores on a scale
STANDARD_DEVIATION 3.41 • n=10 Participants
|
|
Hospital Anxiety and Depression - Depression subscale
|
8.2 scores on a scale
STANDARD_DEVIATION 4.12 • n=5 Participants
|
8.2 scores on a scale
STANDARD_DEVIATION 3.83 • n=7 Participants
|
8.2 scores on a scale
STANDARD_DEVIATION 3.94 • n=5 Participants
|
8.5 scores on a scale
STANDARD_DEVIATION 3.59 • n=4 Participants
|
8.2 scores on a scale
STANDARD_DEVIATION 4.00 • n=21 Participants
|
8.2 scores on a scale
STANDARD_DEVIATION 3.89 • n=10 Participants
|
|
Montgomery Åsberg Depression Rating Scale (MADRS) total score
|
11.83 scores on a scale
STANDARD_DEVIATION 2.787 • n=5 Participants
|
12.24 scores on a scale
STANDARD_DEVIATION 3.279 • n=7 Participants
|
12.24 scores on a scale
STANDARD_DEVIATION 2.895 • n=5 Participants
|
12.47 scores on a scale
STANDARD_DEVIATION 2.868 • n=4 Participants
|
11.99 scores on a scale
STANDARD_DEVIATION 3.087 • n=21 Participants
|
12.16 scores on a scale
STANDARD_DEVIATION 2.989 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=118 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=114 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=111 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=106 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8
|
-11.27 scores on a scale
Standard Error 0.595
|
-12.23 scores on a scale
Standard Error 0.600
|
-11.57 scores on a scale
Standard Error 0.606
|
-11.66 scores on a scale
Standard Error 0.606
|
-13.87 scores on a scale
Standard Error 0.635
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=123 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=120 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=119 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=111 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=108 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8
|
-4.00 scores on a scale
Standard Error 0.361
|
-3.89 scores on a scale
Standard Error 0.364
|
-4.24 scores on a scale
Standard Error 0.366
|
-5.09 scores on a scale
Standard Error 0.372
|
-5.54 scores on a scale
Standard Error 0.385
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=118 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=114 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=111 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=106 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8
|
2.47 scores on a scale
Standard Error 0.091
|
2.36 scores on a scale
Standard Error 0.092
|
2.38 scores on a scale
Standard Error 0.093
|
2.38 scores on a scale
Standard Error 0.093
|
2.03 scores on a scale
Standard Error 0.098
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=97 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=94 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=95 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=94 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=84 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Week 8
|
-6.35 scores on a scale
Standard Error 0.631
|
-6.15 scores on a scale
Standard Error 0.647
|
-6.68 scores on a scale
Standard Error 0.642
|
-7.95 scores on a scale
Standard Error 0.623
|
-8.81 scores on a scale
Standard Error 0.675
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis set; Last observation carried forward (LOCF) was used.
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=149 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Percentage of Responders in HAM-A Total Score at Week 8
|
42.2 percentage of participants
|
44.8 percentage of participants
|
42.6 percentage of participants
|
44.8 percentage of participants
|
51.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=60 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=60 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=50 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=48 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
|
-11.61 scores on a scale
Standard Error 1.008
|
-14.12 scores on a scale
Standard Error 0.945
|
-13.87 scores on a scale
Standard Error 0.955
|
-13.22 scores on a scale
Standard Error 0.999
|
-16.15 scores on a scale
Standard Error 1.039
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 4 and 6Population: Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=149 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Week 1 (n= 151, 149, 142, 149, 143)
|
-4.70 scores on a scale
Standard Error 0.423
|
-4.56 scores on a scale
Standard Error 0.421
|
-4.90 scores on a scale
Standard Error 0.430
|
-5.04 scores on a scale
Standard Error 0.419
|
-5.48 scores on a scale
Standard Error 0.435
|
|
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Week 2 (n=147, 145, 143, 147, 130)
|
-7.30 scores on a scale
Standard Error 0.472
|
-7.28 scores on a scale
Standard Error 0.471
|
-8.22 scores on a scale
Standard Error 0.476
|
-7.63 scores on a scale
Standard Error 0.468
|
-9.29 scores on a scale
Standard Error 0.494
|
|
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Week 4 (n= 139, 135, 132, 133, 116)
|
-8.66 scores on a scale
Standard Error 0.518
|
-9.77 scores on a scale
Standard Error 0.520
|
-9.84 scores on a scale
Standard Error 0.525
|
-9.73 scores on a scale
Standard Error 0.519
|
-11.13 scores on a scale
Standard Error 0.553
|
|
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed
Week 6 (n= 127, 123, 122, 120, 112)
|
-10.28 scores on a scale
Standard Error 0.547
|
-10.82 scores on a scale
Standard Error 0.553
|
-11.26 scores on a scale
Standard Error 0.556
|
-11.05 scores on a scale
Standard Error 0.552
|
-12.66 scores on a scale
Standard Error 0.583
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1 and 4Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=148 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed
Week 1 (n=150, 149, 141, 149, 141)
|
-1.81 scores on a scale
Standard Error 0.273
|
-1.85 scores on a scale
Standard Error 0.274
|
-1.89 scores on a scale
Standard Error 0.280
|
-2.22 scores on a scale
Standard Error 0.272
|
-2.91 scores on a scale
Standard Error 0.285
|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed
Week 4 (n=141, 142, 139, 141, 126)
|
-3.24 scores on a scale
Standard Error 0.310
|
-3.34 scores on a scale
Standard Error 0.310
|
-3.60 scores on a scale
Standard Error 0.313
|
-4.01 scores on a scale
Standard Error 0.310
|
-5.11 scores on a scale
Standard Error 0.328
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 4 and 6Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=147 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=148 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
Week 1 (n=151, 148, 141, 149, 141)
|
3.44 scores on a scale
Standard Error 0.067
|
3.46 scores on a scale
Standard Error 0.068
|
3.41 scores on a scale
Standard Error 0.069
|
3.40 scores on a scale
Standard Error 0.067
|
3.36 scores on a scale
Standard Error 0.070
|
|
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
Week 2 (n=147, 145, 142, 147, 129)
|
3.03 scores on a scale
Standard Error 0.072
|
3.08 scores on a scale
Standard Error 0.072
|
2.90 scores on a scale
Standard Error 0.073
|
2.96 scores on a scale
Standard Error 0.072
|
2.76 scores on a scale
Standard Error 0.077
|
|
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
Week 4 (n=140, 135, 132, 134, 116)
|
2.81 scores on a scale
Standard Error 0.079
|
2.67 scores on a scale
Standard Error 0.080
|
2.67 scores on a scale
Standard Error 0.081
|
2.68 scores on a scale
Standard Error 0.080
|
2.44 scores on a scale
Standard Error 0.085
|
|
Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed
Week 6 (n=127, 123, 121, 120, 112)
|
2.61 scores on a scale
Standard Error 0.082
|
2.53 scores on a scale
Standard Error 0.083
|
2.43 scores on a scale
Standard Error 0.084
|
2.41 scores on a scale
Standard Error 0.083
|
2.25 scores on a scale
Standard Error 0.088
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2 and 4Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=126 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=121 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=118 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=133 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=119 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
Week 1 (n=116, 111, 109, 125, 112)
|
-3.22 scores on a scale
Standard Error 0.506
|
-2.74 scores on a scale
Standard Error 0.521
|
-3.28 scores on a scale
Standard Error 0.521
|
-4.11 scores on a scale
Standard Error 0.483
|
-4.74 scores on a scale
Standard Error 0.521
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
Week 2 (n=116, 114, 116, 123, 103)
|
-4.53 scores on a scale
Standard Error 0.536
|
-4.18 scores on a scale
Standard Error 0.547
|
-5.02 scores on a scale
Standard Error 0.542
|
-5.46 scores on a scale
Standard Error 0.514
|
-7.09 scores on a scale
Standard Error 0.563
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed
Week 4 (n=108, 106, 106, 115, 91)
|
-4.55 scores on a scale
Standard Error 0.590
|
-4.98 scores on a scale
Standard Error 0.604
|
-5.92 scores on a scale
Standard Error 0.600
|
-6.47 scores on a scale
Standard Error 0.568
|
-7.95 scores on a scale
Standard Error 0.632
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4 and 6Population: Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point.
Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=149 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Week 1 (n=151, 149, 142, 149, 143)
|
11.3 percentage of participants
|
6.7 percentage of participants
|
8.5 percentage of participants
|
10.1 percentage of participants
|
16.8 percentage of participants
|
|
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Week 2 (n=154, 154, 147, 154, 149)
|
20.8 percentage of participants
|
20.1 percentage of participants
|
21.1 percentage of participants
|
21.4 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Week 4 (n=154, 154, 148, 154, 149)
|
26.0 percentage of participants
|
30.5 percentage of participants
|
32.4 percentage of participants
|
35.1 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Week 6 (n=154, 154, 148, 154, 149)
|
36.4 percentage of participants
|
37.7 percentage of participants
|
40.5 percentage of participants
|
40.9 percentage of participants
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to weeks 1, 2, 4 and 6Population: Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=80 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=74 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=73 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=70 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
Week 1 (n=63, 76, 70, 70, 66)
|
-5.32 scores on a scale
Standard Error 0.787
|
-6.07 scores on a scale
Standard Error 0.719
|
-5.96 scores on a scale
Standard Error 0.749
|
-5.94 scores on a scale
Standard Error 0.740
|
-6.78 scores on a scale
Standard Error 0.770
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
Week 2 (n=62, 73, 70, 68, 62)
|
-7.55 scores on a scale
Standard Error 0.856
|
-8.82 scores on a scale
Standard Error 0.785
|
-10.18 scores on a scale
Standard Error 0.810
|
-8.51 scores on a scale
Standard Error 0.808
|
-10.40 scores on a scale
Standard Error 0.844
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
Week 4 (n=60, 68, 67, 63, 54)
|
-8.61 scores on a scale
Standard Error 0.901
|
-11.61 scores on a scale
Standard Error 0.837
|
-12.87 scores on a scale
Standard Error 0.854
|
-10.98 scores on a scale
Standard Error 0.862
|
-12.56 scores on a scale
Standard Error 0.914
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
Week 6 (n=58, 63, 62, 54, 51)
|
-10.72 scores on a scale
Standard Error 0.937
|
-12.86 scores on a scale
Standard Error 0.880
|
-14.11 scores on a scale
Standard Error 0.895
|
-12.75 scores on a scale
Standard Error 0.918
|
-14.35 scores on a scale
Standard Error 0.961
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6 and 8Population: Full analysis set. LOCF was used. "n" indicates the number of patients included in the analysis at each time point.
Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=149 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Percentage of Participants in HAM-A Remission at Each Week Assessed
Week 1 (n=151, 149, 142, 149, 143)
|
4.0 percentage of participants
|
2.0 percentage of participants
|
0.7 percentage of participants
|
2.0 percentage of participants
|
4.9 percentage of participants
|
|
Percentage of Participants in HAM-A Remission at Each Week Assessed
Week 2 (n=154, 154, 147, 154, 149)
|
6.5 percentage of participants
|
8.4 percentage of participants
|
7.5 percentage of participants
|
3.9 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Participants in HAM-A Remission at Each Week Assessed
Week 4 (n=154, 154, 148, 154, 149)
|
10.4 percentage of participants
|
13.6 percentage of participants
|
11.5 percentage of participants
|
13.0 percentage of participants
|
17.4 percentage of participants
|
|
Percentage of Participants in HAM-A Remission at Each Week Assessed
Week 6 (n=154, 154, 148, 154, 149)
|
16.2 percentage of participants
|
14.9 percentage of participants
|
14.9 percentage of participants
|
16.9 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants in HAM-A Remission at Each Week Assessed
Week 8 (n=154, 154, 148, 154, 149)
|
22.1 percentage of participants
|
20.1 percentage of participants
|
19.6 percentage of participants
|
20.1 percentage of participants
|
28.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 2, 4, 6 and 8Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=147 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=148 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Week 1 (n=151, 148, 141, 149, 142)
|
-0.42 scores on a scale
Standard Error 0.055
|
-0.37 scores on a scale
Standard Error 0.055
|
-0.39 scores on a scale
Standard Error 0.056
|
-0.42 scores on a scale
Standard Error 0.054
|
-0.54 scores on a scale
Standard Error 0.057
|
|
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Week 2 (n=147, 145, 142, 147, 130)
|
-0.71 scores on a scale
Standard Error 0.066
|
-0.74 scores on a scale
Standard Error 0.066
|
-0.80 scores on a scale
Standard Error 0.067
|
-0.75 scores on a scale
Standard Error 0.065
|
-0.97 scores on a scale
Standard Error 0.069
|
|
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Week 4 (n=140, 135, 132, 134, 115)
|
-0.95 scores on a scale
Standard Error 0.076
|
-1.12 scores on a scale
Standard Error 0.077
|
-1.02 scores on a scale
Standard Error 0.077
|
-1.11 scores on a scale
Standard Error 0.076
|
-1.28 scores on a scale
Standard Error 0.082
|
|
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Week 6 (n=127, 123, 121, 120, 112)
|
-1.22 scores on a scale
Standard Error 0.083
|
-1.32 scores on a scale
Standard Error 0.084
|
-1.31 scores on a scale
Standard Error 0.084
|
-1.35 scores on a scale
Standard Error 0.084
|
-1.55 scores on a scale
Standard Error 0.088
|
|
Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)
Week 8 (n=120, 118, 114, 111, 106)
|
-1.42 scores on a scale
Standard Error 0.095
|
-1.50 scores on a scale
Standard Error 0.096
|
-1.38 scores on a scale
Standard Error 0.097
|
-1.44 scores on a scale
Standard Error 0.097
|
-1.77 scores on a scale
Standard Error 0.101
|
SECONDARY outcome
Timeframe: Baseline to Weeks 1, 4 and 8Population: Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=148 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
Week 1 (n=150, 149, 141, 149, 141)
|
-0.81 scores on a scale
Standard Error 0.226
|
-0.83 scores on a scale
Standard Error 0.226
|
-0.88 scores on a scale
Standard Error 0.231
|
-1.25 scores on a scale
Standard Error 0.225
|
-1.19 scores on a scale
Standard Error 0.235
|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
Week 4 (n=141, 142, 139, 141, 126)
|
-1.32 scores on a scale
Standard Error 0.268
|
-1.83 scores on a scale
Standard Error 0.268
|
-1.70 scores on a scale
Standard Error 0.271
|
-1.61 scores on a scale
Standard Error 0.268
|
-2.62 scores on a scale
Standard Error 0.283
|
|
Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed
Week 8 (n=123, 120, 119, 111, 108)
|
-2.21 scores on a scale
Standard Error 0.300
|
-1.82 scores on a scale
Standard Error 0.303
|
-1.96 scores on a scale
Standard Error 0.305
|
-1.94 scores on a scale
Standard Error 0.310
|
-2.77 scores on a scale
Standard Error 0.320
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=154 Participants
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=148 Participants
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=154 Participants
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=149 Participants
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any resource use
|
34 participants
|
36 participants
|
26 participants
|
43 participants
|
38 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any hospitalization-related services
|
0 participants
|
3 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Hospitalization related to anxiety
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any sick leave
|
14 participants
|
16 participants
|
13 participants
|
15 participants
|
12 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Sick leave related to anxiety
|
5 participants
|
10 participants
|
9 participants
|
9 participants
|
7 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 8: Any resource use
|
26 participants
|
24 participants
|
29 participants
|
23 participants
|
22 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 8: Any hospitalization-related service
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 8: Hospitalization related to anxiety
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 8: Any sick leave
|
13 participants
|
6 participants
|
7 participants
|
7 participants
|
11 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 8: Sick leave related to anxiety
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
4 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Vortioxetine 2.5 mg
Serious events: 1 serious events
Other events: 100 other events
Deaths: 0 deaths
Vortioxetine 5 mg
Serious events: 0 serious events
Other events: 104 other events
Deaths: 0 deaths
Vortioxetine 10 mg
Serious events: 1 serious events
Other events: 111 other events
Deaths: 0 deaths
Duloxetine 60 mg
Serious events: 3 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=155 participants at risk
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=156 participants at risk
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=155 participants at risk
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=156 participants at risk
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=154 participants at risk
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Social circumstances
Sexual abuse
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=155 participants at risk
Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
Vortioxetine 2.5 mg
n=156 participants at risk
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Vortioxetine 5 mg
n=155 participants at risk
Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
|
Vortioxetine 10 mg
n=156 participants at risk
Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
|
Duloxetine 60 mg
n=154 participants at risk
Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
|
|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
17.4%
27/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
26/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
29.0%
45/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
34.0%
53/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.0%
57/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
10/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.0%
14/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.0%
17/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.5%
21/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.2%
25/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
9/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.8%
9/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
11/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.8%
20/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.4%
10/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
12/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
8/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
11/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
11/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.8%
9/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
10/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.8%
6/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
8/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.8%
9/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.7%
15/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Irritability
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.8%
6/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
3.2%
5/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling jittery
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
7/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.0%
14/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
7/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
12/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
9/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
12/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
11/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
12/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
8/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
11/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
12.9%
20/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.5%
18/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.9%
20/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.0%
25/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.9%
26/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
7/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.4%
13/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
8/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.7%
18/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
3.2%
5/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
13/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.8%
9/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.0%
14/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.0%
17/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Tension headache
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Libido decreased
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
7/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
7/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.64%
1/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.6%
4/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.8%
6/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
6/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Restlessness
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
2/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/155 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/156 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
8/154 • From the first dose of double-blind study medication through 30 days after permanent discontinuation of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER