Trial Outcomes & Findings for Duloxetine for the Treatment of Generalized Anxiety Disorder (NCT NCT00803361)
NCT ID: NCT00803361
Last Updated: 2010-12-17
Results Overview
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Baseline, Week 15
Results posted on
2010-12-17
Participant Flow
Participant milestones
| Measure |
Duloxetine
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
102
|
|
Overall Study
COMPLETED
|
82
|
74
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Duloxetine
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
Baseline Characteristics
Duloxetine for the Treatment of Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine
n=108 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=102 Participants
placebo capsules, oral, once a day for 15 weeks
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
37.26 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
38.02 years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
37.63 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
104 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
|
108 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
210 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
China
|
108 participants
n=5 Participants
|
102 participants
n=7 Participants
|
210 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline result within each treatment group.
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Baseline
|
12.76 Units on a scale
Standard Deviation 2.89
|
13.56 Units on a scale
Standard Deviation 2.96
|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
Change from Baseline
|
-6.38 Units on a scale
Standard Deviation 4.44
|
-5.29 Units on a scale
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline result within each treatment group.
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
Baseline
|
24.50 Units on a scale
Standard Deviation 5.81
|
24.24 Units on a scale
Standard Deviation 5.16
|
|
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
Change from Baseline
|
-14.42 Units on a scale
Standard Deviation 9.05
|
-11.62 Units on a scale
Standard Deviation 8.31
|
SECONDARY outcome
Timeframe: Week 15Population: Participants with at least one post-baseline result within each treatment group.
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
|
2.08 Units on a Scale
Standard Deviation 0.97
|
2.54 Units on a Scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline result within each treatment group.
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.
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, General Activity, Change
|
-1.43 Units on a Scale
Standard Deviation 2.40
|
-1.06 Units on a Scale
Standard Deviation 2.43
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Least Pain Baseline
|
1.17 Units on a Scale
Standard Deviation 1.51
|
1.51 Units on a Scale
Standard Deviation 1.81
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Least Pain Change
|
-0.67 Units on a Scale
Standard Deviation 1.32
|
-0.45 Units on a Scale
Standard Deviation 1.70
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Average Pain Baseline
|
2.36 Units on a Scale
Standard Deviation 2.26
|
2.77 Units on a Scale
Standard Deviation 2.20
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Average Pain Change
|
-1.25 Units on a Scale
Standard Deviation 1.94
|
-0.97 Units on a Scale
Standard Deviation 2.06
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Mood, Change
|
-1.49 Units on a Scale
Standard Deviation 2.71
|
-1.44 Units on a Scale
Standard Deviation 2.57
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain,Walking Ability, Change
|
-0.63 Units on a Scale
Standard Deviation 2.01
|
-0.47 Units on a Scale
Standard Deviation 1.95
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Int. of Pain, Normal Work, Change
|
-1.25 Units on a Scale
Standard Deviation 2.54
|
-0.96 Units on a Scale
Standard Deviation 2.43
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Int. of Pain, Relations with Others, Baseline
|
2.01 Units on a Scale
Standard Deviation 2.59
|
2.01 Units on a Scale
Standard Deviation 2.52
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Sleep, Baseline
|
2.55 Units on a Scale
Standard Deviation 3.09
|
3.23 Units on a Scale
Standard Deviation 3.15
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Sleep, Change
|
-1.16 Units on a Scale
Standard Deviation 2.56
|
-1.45 Units on a Scale
Standard Deviation 2.68
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Enjoyment of Life, Baseline
|
2.51 Units on a Scale
Standard Deviation 2.80
|
2.62 Units on a Scale
Standard Deviation 2.37
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Enjoyment of Life, Change
|
-1.27 Units on a Scale
Standard Deviation 2.73
|
-0.99 Units on a Scale
Standard Deviation 2.20
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Mean Interference Score, Baseline
|
2.36 Units on a Scale
Standard Deviation 2.46
|
2.56 Units on a Scale
Standard Deviation 2.25
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Mean Interference Score, Change
|
-1.18 Units on a Scale
Standard Deviation 2.13
|
-1.04 Units on a Scale
Standard Deviation 1.84
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Worst Pain Baseline
|
3.39 Units on a Scale
Standard Deviation 2.84
|
4.22 Units on a Scale
Standard Deviation 3.03
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Worst Pain Change
|
-1.78 Units on a Scale
Standard Deviation 2.44
|
-1.88 Units on a Scale
Standard Deviation 2.78
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Pain Right Now Baseline
|
2.21 Units on a Scale
Standard Deviation 2.58
|
2.30 Units on a Scale
Standard Deviation 2.68
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Severity of Pain Right Now Change
|
-1.41 Units on a Scale
Standard Deviation 2.29
|
-0.77 Units on a Scale
Standard Deviation 2.54
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, General Activity, Baseline
|
2.60 Units on a Scale
Standard Deviation 2.81
|
2.66 Units on a Scale
Standard Deviation 2.69
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain, Mood, Baseline
|
2.97 Units on a Scale
Standard Deviation 3.04
|
3.40 Units on a Scale
Standard Deviation 2.87
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Interference of Pain,Walking Ability, Baseline
|
1.31 Units on a Scale
Standard Deviation 2.07
|
1.56 Units on a Scale
Standard Deviation 2.16
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Int. of Pain, Normal Work, Baseline
|
2.53 Units on a Scale
Standard Deviation 2.77
|
2.44 Units on a Scale
Standard Deviation 2.67
|
|
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
Int. of Pain, Relations with Others, Change
|
-1.07 Units on a Scale
Standard Deviation 2.22
|
-0.88 Units on a Scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline value.
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Work- Baseline (N=101,N=94)
|
5.94 Units on a scale
Standard Deviation 2.01
|
5.85 Units on a scale
Standard Deviation 1.72
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Work- Change(N=101,N=94)
|
-3.27 Units on a scale
Standard Deviation 3.06
|
-2.59 Units on a scale
Standard Deviation 2.69
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Social/Leisure - Baseline
|
5.84 Units on a scale
Standard Deviation 1.89
|
5.73 Units on a scale
Standard Deviation 1.94
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Family Life - Baseline
|
5.50 Units on a scale
Standard Deviation 1.78
|
5.39 Units on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Family Life - Change
|
-3.07 Units on a scale
Standard Deviation 2.55
|
-2.45 Units on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Global Functional Impairment Total Score -Baseline
|
17.24 Units on a scale
Standard Deviation 4.58
|
17.05 Units on a scale
Standard Deviation 4.52
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Global Functional Impairment Total Score -Change
|
-9.51 Units on a scale
Standard Deviation 7.56
|
-7.71 Units on a scale
Standard Deviation 7.15
|
|
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
Symptoms Disrupted Social/Leisure - Change
|
-3.21 Units on a scale
Standard Deviation 2.90
|
-2.60 Units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline result within each treatment group.
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).
Outcome measures
| Measure |
Duloxetine
n=95 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=88 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Overall Pain, Past Week, Baseline
|
27.56 Units on a Scale
Standard Deviation 26.05
|
31.94 Units on a Scale
Standard Deviation 27.62
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Overall Pain, Past Week, Change
|
-15.28 Units on a Scale
Standard Deviation 26.30
|
-13.40 Units on a Scale
Standard Deviation 29.42
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Headaches, Past Week, Baseline
|
21.11 Units on a Scale
Standard Deviation 26.33
|
24.52 Units on a Scale
Standard Deviation 26.68
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Back Pain, Past Week, Change
|
-9.40 Units on a Scale
Standard Deviation 21.19
|
-3.36 Units on a Scale
Standard Deviation 26.55
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Shoulder Pain, Past Week, Baseline
|
16.53 Units on a Scale
Standard Deviation 23.96
|
19.68 Units on a Scale
Standard Deviation 27.74
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Shoulder Pain, Past Week, Change
|
-8.85 Units on a Scale
Standard Deviation 23.55
|
-8.52 Units on a Scale
Standard Deviation 27.12
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Pain Interference, Daily Activities, Baseline
|
27.19 Units on a Scale
Standard Deviation 29.26
|
26.41 Units on a Scale
Standard Deviation 26.03
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Pain Interference, Daily Activities, Change
|
-16.92 Units on a Scale
Standard Deviation 25.41
|
-12.69 Units on a Scale
Standard Deviation 27.53
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Pain During Waking Hours, Past Week, Baseline
|
26.84 Units on a Scale
Standard Deviation -28.48
|
33.22 Units on a Scale
Standard Deviation 33.44
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Pain During Waking Hours, Past Week, Change
|
-16.77 Units on a Scale
Standard Deviation 27.53
|
-14.58 Units on a Scale
Standard Deviation 29.74
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Headaches, Past Week, Change
|
-9.44 Units on a Scale
Standard Deviation 24.61
|
-10.57 Units on a Scale
Standard Deviation 26.36
|
|
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
Severity of Back Pain, Past Week, Baseline
|
18.13 Units on a Scale
Standard Deviation 24.99
|
17.40 Units on a Scale
Standard Deviation 25.41
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: Participants with a baseline and at least one post-baseline result within each treatment group.
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Outcome measures
| Measure |
Duloxetine
n=107 Participants
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=100 Participants
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
Baseline
|
6.90 Units on a Scale
Standard Deviation 3.49
|
6.62 Units on a Scale
Standard Deviation 3.35
|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
Change from Baseline
|
-2.95 Units on a Scale
Standard Deviation 3.82
|
-1.96 Units on a Scale
Standard Deviation 3.60
|
Adverse Events
Duloxetine
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine
n=108 participants at risk
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=102 participants at risk
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/108
|
0.98%
1/102 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine
n=108 participants at risk
60 to 120 mg, capsules, oral, once a day for 15 weeks
|
Placebo
n=102 participants at risk
placebo capsules, oral, once a day for 15 weeks
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
2.8%
3/108 • Number of events 3
|
2.0%
2/102 • Number of events 2
|
|
Eye disorders
Vision blurred
|
2.8%
3/108 • Number of events 3
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.5%
7/108 • Number of events 7
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.3%
10/108 • Number of events 11
|
3.9%
4/102 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108 • Number of events 1
|
3.9%
4/102 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
9.3%
10/108 • Number of events 11
|
3.9%
4/102 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
27.8%
30/108 • Number of events 32
|
8.8%
9/102 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
6/108 • Number of events 6
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Asthenia
|
4.6%
5/108 • Number of events 6
|
0.98%
1/102 • Number of events 1
|
|
General disorders
Fatigue
|
3.7%
4/108 • Number of events 4
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/108
|
2.9%
3/102 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
6/108 • Number of events 6
|
2.0%
2/102 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
3/108 • Number of events 3
|
2.0%
2/102 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
13.9%
15/108 • Number of events 16
|
3.9%
4/102 • Number of events 4
|
|
Nervous system disorders
Headache
|
2.8%
3/108 • Number of events 3
|
3.9%
4/102 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
11.1%
12/108 • Number of events 14
|
0.98%
1/102 • Number of events 2
|
|
Nervous system disorders
Tremor
|
3.7%
4/108 • Number of events 4
|
0.00%
0/102
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/108
|
4.9%
5/102 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
7/108 • Number of events 7
|
2.0%
2/102 • Number of events 2
|
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