Trial Outcomes & Findings for An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain (NCT NCT01914666)
NCT ID: NCT01914666
Last Updated: 2016-01-27
Results Overview
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
Week 53
Results posted on
2016-01-27
Participant Flow
Participant milestones
| Measure |
Naïve
New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
Consecutive participants (randomized to placebo in study F1J-JE-HMGY \[NCT#01855919\]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
68
|
42
|
41
|
|
Treatment Period
Received at Least 1 Dose of Study Drug
|
68
|
42
|
41
|
|
Treatment Period
COMPLETED
|
55
|
36
|
33
|
|
Treatment Period
NOT COMPLETED
|
13
|
6
|
8
|
|
Tapering Period
STARTED
|
59
|
39
|
40
|
|
Tapering Period
COMPLETED
|
59
|
39
|
40
|
|
Tapering Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Naïve
New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
Consecutive participants (randomized to placebo in study F1J-JE-HMGY \[NCT#01855919\]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
2
|
|
Treatment Period
Adverse Event
|
10
|
4
|
2
|
|
Treatment Period
Withdrawal by Subject
|
3
|
2
|
2
|
|
Treatment Period
Physician Decision
|
0
|
0
|
2
|
Baseline Characteristics
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
67 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
67 participants
n=5 Participants
|
42 participants
n=7 Participants
|
41 participants
n=5 Participants
|
150 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 53Population: All the enrolled participants who received at least 1 dose of study drug.
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Naïve
n=68 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
Drug Related AEs
|
42 participants
|
16 participants
|
18 participants
|
|
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
Serious AEs
|
4 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: (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.
A self-reported scale measuring severity of pain and interference on function. Severity scores: 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: 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 = average of non-missing scores of individual interference items.
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Average Pain
|
-3.30 units on a scale
Standard Deviation 1.45
|
-3.79 units on a scale
Standard Deviation 1.66
|
-2.88 units on a scale
Standard Deviation 1.81
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Worst Pain
|
-4.16 units on a scale
Standard Deviation 1.91
|
-4.71 units on a scale
Standard Deviation 2.21
|
-3.24 units on a scale
Standard Deviation 1.88
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Least Pain
|
-1.82 units on a scale
Standard Deviation 1.54
|
-2.52 units on a scale
Standard Deviation 1.77
|
-2.12 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Pain Right Now
|
-2.70 units on a scale
Standard Deviation 1.87
|
-3.93 units on a scale
Standard Deviation 1.74
|
-2.68 units on a scale
Standard Deviation 1.90
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
General Activity
|
-3.22 units on a scale
Standard Deviation 2.30
|
-3.26 units on a scale
Standard Deviation 2.51
|
-2.24 units on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Mood
|
-2.52 units on a scale
Standard Deviation 2.55
|
-3.12 units on a scale
Standard Deviation 2.37
|
-2.07 units on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Walking Ability
|
-2.09 units on a scale
Standard Deviation 2.16
|
-2.74 units on a scale
Standard Deviation 2.26
|
-1.71 units on a scale
Standard Deviation 3.11
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Normal Work
|
-3.22 units on a scale
Standard Deviation 2.49
|
-3.21 units on a scale
Standard Deviation 2.23
|
-2.05 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Relationship with People
|
-1.42 units on a scale
Standard Deviation 2.15
|
-1.79 units on a scale
Standard Deviation 2.37
|
-0.83 units on a scale
Standard Deviation 1.82
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Sleep
|
-1.73 units on a scale
Standard Deviation 2.12
|
-2.40 units on a scale
Standard Deviation 2.56
|
-1.34 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Enjoyment of Life
|
-2.07 units on a scale
Standard Deviation 2.27
|
-2.50 units on a scale
Standard Deviation 2.55
|
-1.83 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Average of 7 Interference Items
|
-2.33 units on a scale
Standard Deviation 1.81
|
-2.72 units on a scale
Standard Deviation 2.05
|
-1.72 units on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Week 50Population: 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.
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).
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
|
2.12 units on a scale
Standard Deviation 0.88
|
2.05 units on a scale
Standard Deviation 0.82
|
2.61 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: 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) score. LOCF was used.
CGI-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).
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
|
2.09 units on a scale
Standard Deviation 0.81
|
2.00 units on a scale
Standard Deviation 0.73
|
2.73 units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: 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) score. LOCF was used.
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
|
-3.69 units on a scale
Standard Deviation 3.76
|
-5.50 units on a scale
Standard Deviation 5.64
|
-3.29 units on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: 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) score. 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.
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Vitality
|
10.07 units on a scale
Standard Deviation 16.64
|
13.24 units on a scale
Standard Deviation 23.15
|
6.10 units on a scale
Standard Deviation 18.93
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Physical Functioning
|
10.60 units on a scale
Standard Deviation 15.21
|
9.52 units on a scale
Standard Deviation 21.91
|
10.12 units on a scale
Standard Deviation 17.66
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Role (Physical)
|
16.88 units on a scale
Standard Deviation 20.73
|
11.31 units on a scale
Standard Deviation 24.24
|
7.01 units on a scale
Standard Deviation 21.66
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Bodily Pain
|
17.64 units on a scale
Standard Deviation 16.32
|
20.26 units on a scale
Standard Deviation 22.09
|
12.62 units on a scale
Standard Deviation 16.58
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
General Health
|
8.42 units on a scale
Standard Deviation 13.81
|
8.90 units on a scale
Standard Deviation 14.54
|
5.51 units on a scale
Standard Deviation 18.57
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Social Functioning
|
6.90 units on a scale
Standard Deviation 21.24
|
8.63 units on a scale
Standard Deviation 19.22
|
3.35 units on a scale
Standard Deviation 20.16
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Role (Emotional)
|
11.57 units on a scale
Standard Deviation 20.05
|
11.51 units on a scale
Standard Deviation 23.20
|
4.47 units on a scale
Standard Deviation 16.99
|
|
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Mental Health
|
5.97 units on a scale
Standard Deviation 15.31
|
8.81 units on a scale
Standard Deviation 14.89
|
4.63 units on a scale
Standard Deviation 14.12
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: 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.
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 three 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.
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
|
0.16 units on a scale
Standard Deviation 0.16
|
0.15 units on a scale
Standard Deviation 0.15
|
0.11 units on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: 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 was used.
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Outcome measures
| Measure |
Naïve
n=67 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
|
-1.81 units on a scale
Standard Deviation 5.32
|
-1.83 units on a scale
Standard Deviation 5.00
|
-0.56 units on a scale
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: Baseline, Week 53Population: 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.LOCF was used.
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any 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 one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Outcome measures
| Measure |
Naïve
n=65 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=39 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=40 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
Suicidal Ideation- wish to be dead (n=65,39,40)
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
Nonspecific suicidal thoughts (n=67,42,41)
|
0 participants
|
0 participants
|
0 participants
|
|
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
Suicidal Behavior (n=67,42,41)
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 53Population: All the enrolled 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 |
Naïve
n=68 Participants
New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Placebo)
n=42 Participants
Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
Rollover (Pre-Duloxetine 60 mg)
n=41 Participants
Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
|
|---|---|---|---|
|
Number of Participants With Fall Events From Fall Questionnaire
|
13 participants
|
5 participants
|
6 participants
|
Adverse Events
Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)
Serious events: 8 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)
n=151 participants at risk
All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
|
|---|---|
|
Eye disorders
Angle closure glaucoma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Brain stem infarction
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)
n=151 participants at risk
All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.0%
3/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
5/151 • Number of events 5
AEs for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Eye disorders
Chalazion
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.6%
7/151 • Number of events 7
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.9%
15/151 • Number of events 15
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
8/151 • Number of events 8
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyschezia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.6%
16/151 • Number of events 18
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Feeling abnormal
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
Thirst
|
6.0%
9/151 • Number of events 9
AEs for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Sarcoidosis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Acute tonsillitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.0%
6/151 • Number of events 7
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
1.3%
2/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Erythema infectiosum
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
5/151 • Number of events 6
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingival abscess
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingival infection
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
1.3%
2/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected dermal cyst
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
4.6%
7/151 • Number of events 7
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
24.5%
37/151 • Number of events 48
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Periodontitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
3.3%
5/151 • Number of events 5
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.66%
1/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
11.3%
17/151 • Number of events 26
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
3.3%
5/151 • Number of events 5
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Heat illness
|
1.3%
2/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
8/151 • Number of events 12
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.66%
1/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Liver function test abnormal
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
Occult blood
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
11/151 • Number of events 13
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
5/151 • Number of events 6
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
3/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
5.3%
8/151 • Number of events 10
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton's neuroma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.3%
8/151 • Number of events 11
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
3.3%
5/151 • Number of events 5
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.6%
10/151 • Number of events 11
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Myelopathy
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Radiculitis cervical
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
19.2%
29/151 • Number of events 30
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.6%
4/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hypertonic bladder
|
2.0%
3/151 • Number of events 3
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.2%
1/81 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
1.4%
1/70 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.2%
1/81 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.66%
1/151 • Number of events 4
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria cholinergic
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.3%
2/151 • Number of events 2
AEs for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.66%
1/151 • Number of events 1
AEs for all participants who received at least one 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