Trial Outcomes & Findings for A Study of Duloxetine in Fibromyalgia (NCT NCT01552057)
NCT ID: NCT01552057
Last Updated: 2015-01-16
Results Overview
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
393 participants
Primary outcome timeframe
Baseline, 14 weeks
Results posted on
2015-01-16
Participant Flow
Randomized participants who completed the 14-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 1-week taper and were observed 1 week post-treatment for safety.
Participant milestones
| Measure |
Duloxetine 60 mg
Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.
|
Placebo
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
197
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
194
|
196
|
|
Overall Study
COMPLETED
|
166
|
149
|
|
Overall Study
NOT COMPLETED
|
30
|
48
|
Reasons for withdrawal
| Measure |
Duloxetine 60 mg
Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.
|
Placebo
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
15
|
|
Overall Study
Lack of Efficacy
|
8
|
23
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Entry Criteria Not Met
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Study of Duloxetine in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
49.5 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
48.7 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=93 Participants
|
164 Participants
n=4 Participants
|
321 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
191 participants
n=93 Participants
|
195 participants
n=4 Participants
|
386 participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
191 participants
n=93 Participants
|
195 participants
n=4 Participants
|
386 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
|
-1.90 units on a scale
Standard Error 0.23
|
-1.58 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Baseline, 2 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
|
-1.00 units on a scale
Standard Error 0.21
|
-0.60 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
|
-1.55 units on a scale
Standard Error 0.22
|
-0.94 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
|
-1.81 units on a scale
Standard Error 0.22
|
-1.09 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Baseline, 10 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)
|
-1.85 units on a scale
Standard Error 0.23
|
-1.41 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Baseline, up to 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.
BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)
|
-1.60 units on a scale
Standard Error 0.26
|
-1.22 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Patients Global Impression of Improvement (PGI-I) at Endpoint
|
2.83 units on a scale
Standard Error 0.16
|
3.32 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) at Endpoint
|
2.83 units on a scale
Standard Error 0.15
|
3.27 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)
|
-18.41 units on a scale
Standard Error 2.57
|
-13.05 units on a scale
Standard Error 2.65
|
SECONDARY outcome
Timeframe: Baseline, up to 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.
The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Vitality
|
10.05 units on a scale
Standard Error 2.51
|
3.35 units on a scale
Standard Error 2.53
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Physical Functioning
|
7.40 units on a scale
Standard Error 2.13
|
3.06 units on a scale
Standard Error 2.15
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Role-Physical
|
8.20 units on a scale
Standard Error 2.96
|
0.44 units on a scale
Standard Error 2.98
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Bodily Pain
|
10.95 units on a scale
Standard Error 2.07
|
5.28 units on a scale
Standard Error 2.08
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
General Health
|
6.55 units on a scale
Standard Error 1.92
|
3.31 units on a scale
Standard Error 1.94
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Social Functioning
|
10.32 units on a scale
Standard Error 3.04
|
3.28 units on a scale
Standard Error 3.06
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Role-Emotional
|
5.50 units on a scale
Standard Error 3.35
|
-3.63 units on a scale
Standard Error 3.36
|
|
Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores
Mental Health
|
5.91 units on a scale
Standard Error 2.51
|
-2.00 units on a scale
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)
|
-4.07 units on a scale
Standard Error 0.84
|
-1.22 units on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms \[each rated from 0 (no problem) to 3 (severe; life-disturbing problems)\] plus the severity of somatic symptoms in general \[rated from 0 (no symptoms) to 3 (a great deal of symptoms)\]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
WPI
|
-2.34 units on a scale
Standard Error 0.58
|
-1.06 units on a scale
Standard Error 0.60
|
|
Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010
SS
|
-1.37 units on a scale
Standard Error 0.27
|
-1.00 units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary
Average Pain
|
-1.82 units on a scale
Standard Error 0.18
|
-1.48 units on a scale
Standard Error 0.18
|
|
Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary
Worst Pain
|
-1.81 units on a scale
Standard Error 0.19
|
-1.34 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.
Outcome measures
| Measure |
Duloxetine 60 mg
n=191 Participants
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
|
Placebo
n=195 Participants
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
|
|---|---|---|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Least Pain
|
-1.72 units on a scale
Standard Error 0.22
|
-1.23 units on a scale
Standard Error 0.22
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With General Activity
|
-2.22 units on a scale
Standard Error 0.31
|
-1.76 units on a scale
Standard Error 0.32
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Normal Work
|
-2.18 units on a scale
Standard Error 0.31
|
-1.76 units on a scale
Standard Error 0.32
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Worst Pain
|
-1.91 units on a scale
Standard Error 0.26
|
-1.35 units on a scale
Standard Error 0.26
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Pain Right Now
|
-1.77 units on a scale
Standard Error 0.26
|
-1.20 units on a scale
Standard Error 0.26
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Mood
|
-2.17 units on a scale
Standard Error 0.32
|
-1.42 units on a scale
Standard Error 0.33
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Walking Ability
|
-1.67 units on a scale
Standard Error 0.29
|
-1.29 units on a scale
Standard Error 0.30
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Relations With Other People
|
-1.09 units on a scale
Standard Error 0.30
|
-0.53 units on a scale
Standard Error 0.30
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Sleep
|
-1.82 units on a scale
Standard Error 0.35
|
-1.57 units on a scale
Standard Error 0.36
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Interference With Enjoyment of Life
|
-1.90 units on a scale
Standard Error 0.31
|
-1.24 units on a scale
Standard Error 0.32
|
|
Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form
Average Interference
|
-1.95 units on a scale
Standard Error 0.27
|
-1.44 units on a scale
Standard Error 0.27
|
Adverse Events
Duloxetine 60 mg
Serious events: 1 serious events
Other events: 147 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine 60 mg
n=194 participants at risk
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.
|
Placebo
n=196 participants at risk
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.
|
|---|---|---|
|
Hepatobiliary disorders
Liver disorder
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Duloxetine 60 mg
n=194 participants at risk
Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.
|
Placebo
n=196 participants at risk
Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
2.6%
5/194 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
4/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
5/194 • Number of events 6 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.6%
5/196 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
4/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
6/194 • Number of events 6 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
14.9%
29/194 • Number of events 29 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
4.1%
8/196 • Number of events 8 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
8/194 • Number of events 8 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
3.6%
7/196 • Number of events 8 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
21.6%
42/194 • Number of events 44 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
4.6%
9/196 • Number of events 9 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
2.1%
4/194 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.5%
3/196 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
7/194 • Number of events 7 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
2.1%
4/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
1.0%
2/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
4.6%
9/194 • Number of events 9 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
3.1%
6/196 • Number of events 6 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
General disorders
Thirst
|
7.2%
14/194 • Number of events 14 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
3.6%
7/196 • Number of events 7 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.6%
5/194 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
1.5%
3/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.5%
3/196 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Gingivitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Impetigo
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.5%
3/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Keratitis bacterial
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
26/194 • Number of events 39 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
14.8%
29/196 • Number of events 37 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Pertussis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
2/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
3/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.5%
3/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.5%
3/196 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
2.6%
5/194 • Number of events 6 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
3/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.5%
3/196 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Blood urine present
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
4/194 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Heart rate increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Protein total decreased
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Protein urine present
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Red blood cell count decreased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Red blood cell count increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
13/194 • Number of events 13 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.7%
11/194 • Number of events 11 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dyskinesia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Head discomfort
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
4.6%
9/194 • Number of events 11 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
3.1%
6/196 • Number of events 6 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sleep paralysis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
26.3%
51/194 • Number of events 52 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
10.7%
21/196 • Number of events 21 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.6%
5/196 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Limited symptom panic attack
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Middle insomnia
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
1.5%
3/194 • Number of events 3 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/35 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.63%
1/159 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/165 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.63%
1/159 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/165 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.52%
1/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
4.1%
8/196 • Number of events 8 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.0%
2/194 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.51%
1/196 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
5/194 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
4/194 • Number of events 5 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
1.0%
2/196 • Number of events 2 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/194 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
2.0%
4/196 • Number of events 4 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.52%
1/194 • Number of events 1 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
0.00%
0/196 • Baseline through 1 week post last dose
Randomized who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60