Trial Outcomes & Findings for A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain (NCT NCT01855919)
NCT ID: NCT01855919
Last Updated: 2015-07-23
Results Overview
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.
COMPLETED
PHASE3
458 participants
Baseline, Week 14
2015-07-23
Participant Flow
The participant flow includes information on participants who completed the study. 2 participants who were assigned to receive placebo received duloxetine instead. These participants were treated as placebo in efficacy analysis and as duloxetine in safety analysis. In the participant flow, these participants are included under placebo.
Participant milestones
| Measure |
Duloxetine
Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
226
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
232
|
226
|
|
Overall Study
COMPLETED
|
209
|
200
|
|
Overall Study
NOT COMPLETED
|
23
|
26
|
Reasons for withdrawal
| Measure |
Duloxetine
Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Entry Criteria Not Met
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
4
|
Baseline Characteristics
A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
230 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
230 participants
n=5 Participants
|
226 participants
n=7 Participants
|
456 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item
|
-2.43 units on a scale
Standard Error 0.11
|
-1.96 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) at Week 14
|
2.46 units on a scale
Standard Error 0.07
|
2.76 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.
The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14
|
-3.86 units on a scale
Standard Error 0.22
|
-3.23 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Worst Pain
|
-2.63 units on a scale
Standard Error 0.13
|
-2.33 units on a scale
Standard Error 0.13
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Least Pain
|
-1.69 units on a scale
Standard Error 0.10
|
-1.19 units on a scale
Standard Error 0.11
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Current Pain
|
-2.42 units on a scale
Standard Error 0.12
|
-2.03 units on a scale
Standard Error 0.12
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
General Activity
|
-2.46 units on a scale
Standard Error 0.13
|
-2.16 units on a scale
Standard Error 0.13
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Mood
|
-2.15 units on a scale
Standard Error 0.11
|
-1.83 units on a scale
Standard Error 0.11
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Walking Ability
|
-2.05 units on a scale
Standard Error 0.11
|
-1.92 units on a scale
Standard Error 0.11
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Normal Work
|
-2.17 units on a scale
Standard Error 0.12
|
-2.17 units on a scale
Standard Error 0.12
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Relationship People
|
-1.02 units on a scale
Standard Error 0.10
|
-0.98 units on a scale
Standard Error 0.10
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Sleep
|
-1.41 units on a scale
Standard Error 0.11
|
-1.40 units on a scale
Standard Error 0.11
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Enjoyment of Life
|
-1.52 units on a scale
Standard Error 0.11
|
-1.48 units on a scale
Standard Error 0.11
|
|
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14
Average of 7 Interference Items
|
-1.83 units on a scale
Standard Error 0.10
|
-1.70 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14
Average Pain
|
-2.15 units on a scale
Standard Error 0.10
|
-1.73 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14
Worst Pain
|
-2.25 units on a scale
Standard Error 0.12
|
-1.91 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) \* 100.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14
≥30% pain reduction
|
68.7 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14
≥50% pain reduction
|
56.5 percentage of participants
|
39.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) \* 100.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score
|
61.3 percentage of participants
|
46.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.
CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14
|
-1.46 units on a scale
Standard Error 0.06
|
-1.17 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14
|
-1.39 units on a scale
Standard Error 0.24
|
-1.04 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Physical Functioning
|
8.47 units on a scale
Standard Error 0.79
|
7.20 units on a scale
Standard Error 0.80
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Role (Physical)
|
10.58 units on a scale
Standard Error 1.15
|
10.00 units on a scale
Standard Error 1.16
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Bodily Pain
|
12.56 units on a scale
Standard Error 0.94
|
11.01 units on a scale
Standard Error 0.95
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
General Health
|
6.72 units on a scale
Standard Error 0.85
|
3.78 units on a scale
Standard Error 0.86
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Vitality
|
5.56 units on a scale
Standard Error 0.97
|
4.41 units on a scale
Standard Error 0.97
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Social Functioning
|
6.40 units on a scale
Standard Error 1.00
|
4.77 units on a scale
Standard Error 1.01
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Role (Emotional)
|
5.78 units on a scale
Standard Error 1.13
|
6.18 units on a scale
Standard Error 1.14
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14
Mental Health
|
5.63 units on a scale
Standard Error 0.81
|
2.42 units on a scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF.
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14
|
0.09 units on a scale
Standard Error 0.01
|
0.08 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))\*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)\*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\])\*100); and Activity Impairment=(Q6/10)\*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.
Outcome measures
| Measure |
Duloxetine
n=230 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=226 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14
Work activity impairment (n=230, 226)
|
-0.14 hours
Standard Error 0.01
|
-0.12 hours
Standard Error 0.01
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14
Work time missed (n=135, 140)
|
-0.01 hours
Standard Error 0.01
|
0.02 hours
Standard Error 0.01
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14
Impairment at work (n=136, 140)
|
-0.13 hours
Standard Error 0.02
|
-0.09 hours
Standard Error 0.02
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14
Work productivity loss (n=135, 140)
|
-0.13 hours
Standard Error 0.02
|
-0.09 hours
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Outcome measures
| Measure |
Duloxetine
n=232 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=224 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]
Wish to be dead (n=226, 220)
|
0 percentage of participants
|
0 percentage of participants
|
|
Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]
Nonspecific active suicidal thoughts (n=231, 223)
|
0 percentage of participants
|
0 percentage of participants
|
|
Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]
Suicidal behavior (n=232, 224)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: All randomized participants who received at least 1 dose of study drug.
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) \* 100.
Outcome measures
| Measure |
Duloxetine
n=234 Participants
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=224 Participants
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Percentage of Participants With Fall Events in Fall Questionnaire
|
10.3 percentage of participants
|
8.0 percentage of participants
|
Adverse Events
Duloxetine
Placebo
Serious adverse events
| Measure |
Duloxetine
n=234 participants at risk
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=224 participants at risk
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Gastric polyps
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Calculus urethral
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine
n=234 participants at risk
Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
|
Placebo
n=224 participants at risk
Placebo administered in capsule form orally once every day for 15 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Cardiac disorders
Bundle branch block right
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Cardiac disorders
Palpitations
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Ear and labyrinth disorders
Motion sickness
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Ear and labyrinth disorders
Tinnitus
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
5/234 • Number of events 5
|
0.00%
0/224
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Eye disorders
Conjunctivitis
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Eye disorders
Conjunctivitis allergic
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Eye disorders
Vision blurred
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
8/234 • Number of events 8
|
1.3%
3/224 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
3/234 • Number of events 3
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.85%
2/234 • Number of events 2
|
0.89%
2/224 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
10.7%
25/234 • Number of events 25
|
2.2%
5/224 • Number of events 5
|
|
Gastrointestinal disorders
Dental caries
|
1.7%
4/234 • Number of events 4
|
0.89%
2/224 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
9/234 • Number of events 10
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
4/234 • Number of events 4
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Gastrointestinal disorders
Nausea
|
9.0%
21/234 • Number of events 21
|
2.7%
6/224 • Number of events 6
|
|
Gastrointestinal disorders
Saliva altered
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Gastrointestinal disorders
Stomatitis
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
General disorders
Asthenia
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
General disorders
Calcinosis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
General disorders
Chest pain
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
General disorders
Face oedema
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
General disorders
Feeling abnormal
|
0.85%
2/234 • Number of events 3
|
0.45%
1/224 • Number of events 1
|
|
General disorders
Malaise
|
3.4%
8/234 • Number of events 9
|
1.3%
3/224 • Number of events 3
|
|
General disorders
Oedema peripheral
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
General disorders
Thirst
|
6.0%
14/234 • Number of events 14
|
0.00%
0/224
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
3.0%
7/234 • Number of events 7
|
0.89%
2/224 • Number of events 2
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.3%
3/234 • Number of events 3
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Gingival abscess
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Infections and infestations
Gingival infection
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Infections and infestations
Gingivitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.43%
1/234 • Number of events 1
|
1.3%
3/224 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
26/234 • Number of events 33
|
17.4%
39/224 • Number of events 43
|
|
Infections and infestations
Oral herpes
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Otitis externa
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Periodontitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Pertussis
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Infections and infestations
Pharyngitis
|
1.3%
3/234 • Number of events 3
|
0.00%
0/224
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Purulence
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/234
|
0.45%
1/224 • Number of events 2
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.85%
2/234 • Number of events 2
|
0.89%
2/224 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
16/234 • Number of events 18
|
3.1%
7/224 • Number of events 8
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/234
|
0.89%
2/224 • Number of events 2
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Fall
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.1%
5/234 • Number of events 5
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Nerve root injury cervical
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.7%
4/234 • Number of events 5
|
0.89%
2/224 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
4/234 • Number of events 4
|
0.00%
0/224
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
3/234 • Number of events 3
|
0.00%
0/224
|
|
Investigations
Blood bilirubin increased
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
1.7%
4/234 • Number of events 4
|
1.3%
3/224 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Investigations
Blood urine present
|
0.43%
1/234 • Number of events 1
|
0.89%
2/224 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Glucose urine present
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
2.6%
6/234 • Number of events 6
|
1.3%
3/224 • Number of events 3
|
|
Investigations
Platelet count increased
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
10/234 • Number of events 10
|
0.45%
1/224 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Metabolism and nutrition disorders
Periarthritis calcarea
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
7/234 • Number of events 7
|
2.7%
6/224 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
4/234 • Number of events 4
|
0.89%
2/224 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Cartilage hypertrophy
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Musculoskeletal and connective tissue disorders
Infrapatellar fat pad inflammation
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/234
|
1.3%
3/224 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/234
|
1.3%
3/224 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
3/234 • Number of events 3
|
3.6%
8/224 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/234
|
1.8%
4/224 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.3%
3/234 • Number of events 3
|
2.7%
6/224 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/234
|
2.2%
5/224 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
6.4%
15/234 • Number of events 16
|
0.89%
2/224 • Number of events 2
|
|
Nervous system disorders
Dizziness postural
|
1.7%
4/234 • Number of events 4
|
0.00%
0/224
|
|
Nervous system disorders
Dysarthria
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Dysgeusia
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
9/234 • Number of events 9
|
1.3%
3/224 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Migraine
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Somnolence
|
19.2%
45/234 • Number of events 45
|
7.1%
16/224 • Number of events 17
|
|
Nervous system disorders
Tension headache
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Nervous system disorders
Tremor
|
1.7%
4/234 • Number of events 4
|
0.00%
0/224
|
|
Psychiatric disorders
Anxiety
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Psychiatric disorders
Dysphoria
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Psychiatric disorders
Sleep talking
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Chromaturia
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Dysuria
|
2.1%
5/234 • Number of events 5
|
0.00%
0/224
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.43%
1/234 • Number of events 1
|
0.45%
1/224 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Urinary retention
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Renal and urinary disorders
Urine flow decreased
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.86%
1/116 • Number of events 1
|
0.00%
0/103
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.85%
1/118 • Number of events 1
|
0.83%
1/121 • Number of events 2
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/118
|
0.83%
1/121 • Number of events 1
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.85%
2/234 • Number of events 2
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/234 • Number of events 1
|
0.89%
2/224 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
3/234 • Number of events 4
|
0.45%
1/224 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.85%
2/234 • Number of events 2
|
0.45%
1/224 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/234
|
0.89%
2/224 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/234
|
0.89%
2/224 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
3/234 • Number of events 4
|
1.3%
3/224 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
3/234 • Number of events 3
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/234
|
1.3%
3/224 • Number of events 3
|
|
Vascular disorders
Hot flush
|
0.43%
1/234 • Number of events 1
|
0.00%
0/224
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/234
|
0.45%
1/224 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60