Trial Outcomes & Findings for An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480) (NCT NCT02335346)
NCT ID: NCT02335346
Last Updated: 2019-09-18
Results Overview
A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
COMPLETED
PHASE3
93 participants
Baseline through Week 53
2019-09-18
Participant Flow
All participants were consecutive participants from F1J-JE-HMGX, NCT02248480. No new participants were enrolled.
Participant milestones
| Measure |
Duloxetine
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
93
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Duloxetine
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
Baseline characteristics by cohort
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
93 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 53Population: All enrolled participants who received at least one dose of study drug.
A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Serious Adverse Event
|
7.5 Percentage of participants
|
|
Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Drug-Related Adverse Event
|
51.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
Patient Global Impressions of Improvement Scale: 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 |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Patient Global Impression-Improvement (PGI-I) at 50 Weeks
|
2.09 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
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).
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50
|
-2.19 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales 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 |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Worst Pain
|
-4.29 units on a scale
Standard Deviation 2.05
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Least Pain
|
-2.16 units on a scale
Standard Deviation 1.66
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Average Pain
|
-3.33 units on a scale
Standard Deviation 1.81
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Pain Right Now
|
-2.94 units on a scale
Standard Deviation 2.19
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
General Activity
|
-3.03 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Mood
|
-2.48 units on a scale
Standard Deviation 2.25
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Walking Ability
|
-3.11 units on a scale
Standard Deviation 2.17
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Normal Work
|
-3.10 units on a scale
Standard Deviation 2.41
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Relationship People
|
-1.43 units on a scale
Standard Deviation 2.07
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Sleep
|
-1.81 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Enjoy of Life
|
-1.92 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)
Average of 7 items
|
-2.41 units on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 millimeter (mm)(extreme).
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score
|
-20.23 units on a scale
Standard Deviation 15.05
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
36-item Short-Form Health Survey: 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. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-6); social functioning (range: 2-10); bodily pain (range: 2-11); vitality (range: 4-24); mental health (range: 5-30).
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Physical Functioning
|
15.27 units on a scale
Standard Deviation 20.82
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Role (Physical)
|
11.90 units on a scale
Standard Deviation 21.20
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Bodily Pain
|
21.32 units on a scale
Standard Deviation 21.15
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
General Health
|
10.89 units on a scale
Standard Deviation 17.20
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Vitality
|
9.61 units on a scale
Standard Deviation 16.16
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Social Functioning
|
6.45 units on a scale
Standard Deviation 19.12
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Role(Emotional)
|
8.78 units on a scale
Standard Deviation 23.13
|
|
Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)
Mental Health
|
4.89 units on a scale
Standard Deviation 18.37
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (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 anxiety/depression 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 with scores ranging from -0.111 to 1.0. A higher score indicates better health state.
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument
|
0.15 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).
Beck Depression Inventory-II: 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 |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score
|
-1.14 units on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Baseline through Week 50Population: All enrolled participants who received at least one dose of study drug.
Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group \* 100.
Outcome measures
| Measure |
Duloxetine
n=93 Participants
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Percentage of Participants With Fall Events From Fall Questionnaire
|
23.7 Percentage of Participants
|
Adverse Events
Duloxetine
Serious adverse events
| Measure |
Duloxetine
n=93 participants at risk
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Enteritis infectious
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Progressive supranuclear palsy
|
1.1%
1/93 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine
n=93 participants at risk
Duloxetine 20 mg for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
|
|---|---|
|
Investigations
Urobilinogen urine increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Weight increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
White blood cell count increased
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
1/93 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
5/93 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.1%
1/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
3.2%
3/93 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.3%
4/93 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myofascitis
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
2/93 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.2%
2/93 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.2%
2/93 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/93 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/93 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/93 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Chalazion
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Dry eye
|
1.1%
1/93 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/93 • Number of events 2
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
19.4%
18/93 • Number of events 20
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Gingival swelling
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.3%
4/93 • Number of events 5
|
|
Gastrointestinal disorders
Stomatitis
|
2.2%
2/93 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/93 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/93 • Number of events 1
|
|
General disorders
Malaise
|
2.2%
2/93 • Number of events 2
|
|
General disorders
Peripheral swelling
|
2.2%
2/93 • Number of events 2
|
|
General disorders
Thirst
|
11.8%
11/93 • Number of events 11
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
1.1%
1/93 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Acute sinusitis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
5.4%
5/93 • Number of events 6
|
|
Infections and infestations
Chronic sinusitis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Cystitis
|
2.2%
2/93 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Gingivitis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
4.3%
4/93 • Number of events 4
|
|
Infections and infestations
Influenza
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
16.1%
15/93 • Number of events 21
|
|
Infections and infestations
Onychomycosis
|
2.2%
2/93 • Number of events 2
|
|
Infections and infestations
Oral herpes
|
3.2%
3/93 • Number of events 3
|
|
Infections and infestations
Otitis media chronic
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Paronychia
|
1.1%
1/93 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
4.3%
4/93 • Number of events 4
|
|
Infections and infestations
Purulence
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.2%
2/93 • Number of events 2
|
|
Infections and infestations
Tinea pedis
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/93 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
1/93 • Number of events 3
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
8.6%
8/93 • Number of events 11
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
2.2%
2/93 • Number of events 2
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.2%
2/93 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Frostbite
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heat illness
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.5%
6/93 • Number of events 6
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Stab wound
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.1%
1/93 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
2/93 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood potassium increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood pressure increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood uric acid increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Blood urine present
|
2.2%
2/93 • Number of events 2
|
|
Investigations
Glycosylated haemoglobin increased
|
2.2%
2/93 • Number of events 2
|
|
Investigations
International normalised ratio increased
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
1.1%
1/93 • Number of events 1
|
|
Investigations
Protein urine present
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
4.3%
4/93 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.1%
1/93 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
1.1%
1/93 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Cervical radiculopathy
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.4%
5/93 • Number of events 5
|
|
Nervous system disorders
Headache
|
2.2%
2/93 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
2/93 • Number of events 2
|
|
Nervous system disorders
Intercostal neuralgia
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Migraine
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/93 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
3.2%
3/93 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
12.9%
12/93 • Number of events 12
|
|
Psychiatric disorders
Disorientation
|
1.1%
1/93 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.2%
2/93 • Number of events 2
|
|
Psychiatric disorders
Neurosis
|
1.1%
1/93 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/93 • Number of events 1
|
|
Renal and urinary disorders
Hypertonic bladder
|
1.1%
1/93 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
2/93 • Number of events 2
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/93 • Number of events 2
|
|
Renal and urinary disorders
Stress urinary incontinence
|
1.1%
1/93 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
4/93 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
5/93 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/93 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
2/93 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.3%
4/93 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
3/93 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
2/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.1%
1/93 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
3/93 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
1.1%
1/93 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Hypertension
|
7.5%
7/93 • Number of events 7
|
|
Vascular disorders
Lymphoedema
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
1.1%
1/93 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.1%
1/93 • 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