Trial Outcomes & Findings for A Study in Participants With Diabetic Peripheral Neuropathic Pain in China (NCT NCT01179672)
NCT ID: NCT01179672
Last Updated: 2014-10-13
Results Overview
24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2014-10-13
Participant Flow
Participants tapered off study drug after either completing the 12 weeks of treatment or discontinued treatment early.
Participant milestones
| Measure |
Duloxetine
30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
|
Placebo
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
202
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
202
|
202
|
|
Overall Study
Entered Taper
|
181
|
177
|
|
Overall Study
COMPLETED
|
173
|
176
|
|
Overall Study
NOT COMPLETED
|
30
|
26
|
Reasons for withdrawal
| Measure |
Duloxetine
30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
|
Placebo
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
8
|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
|
Overall Study
Entry Criteria Not Met
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
A Study in Participants With Diabetic Peripheral Neuropathic Pain in China
Baseline characteristics by cohort
| Measure |
Duloxetine
n=203 Participants
30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=202 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.56 years
STANDARD_DEVIATION 9.65 • n=93 Participants
|
61.17 years
STANDARD_DEVIATION 9.42 • n=4 Participants
|
61.37 years
STANDARD_DEVIATION 9.52 • n=27 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
223 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
182 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
203 Participants
n=93 Participants
|
202 Participants
n=4 Participants
|
405 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
203 Participants
n=93 Participants
|
202 Participants
n=4 Participants
|
405 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
203 participants
n=93 Participants
|
202 participants
n=4 Participants
|
405 participants
n=27 Participants
|
|
Diabetes Disease Characteristics-Types of Diabetes
Type I Diabetes
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Diabetes Disease Characteristics-Types of Diabetes
Type II Diabetes
|
200 participants
n=93 Participants
|
199 participants
n=4 Participants
|
399 participants
n=27 Participants
|
|
Diabetes Disease Characteristics
Duration of Diabetes
|
11.53 years
STANDARD_DEVIATION 6.81 • n=93 Participants
|
11.38 years
STANDARD_DEVIATION 7.47 • n=4 Participants
|
11.45 years
STANDARD_DEVIATION 7.14 • n=27 Participants
|
|
Diabetes Disease Characteristics
Duration of Diabetic Neuropathy
|
3.47 years
STANDARD_DEVIATION 3.91 • n=93 Participants
|
3.07 years
STANDARD_DEVIATION 3.13 • n=4 Participants
|
3.27 years
STANDARD_DEVIATION 3.55 • n=27 Participants
|
|
Diabetes Disease Characteristics
Duration of Diabetic Neuropathy Pain
|
3.06 years
STANDARD_DEVIATION 3.70 • n=93 Participants
|
2.59 years
STANDARD_DEVIATION 2.69 • n=4 Participants
|
2.83 years
STANDARD_DEVIATION 3.24 • n=27 Participants
|
|
Weekly Mean of 24-Hour Average Pain
|
5.72 units on a scale
STANDARD_DEVIATION 1.72 • n=93 Participants
|
5.62 units on a scale
STANDARD_DEVIATION 1.66 • n=4 Participants
|
5.67 units on a scale
STANDARD_DEVIATION 1.69 • n=27 Participants
|
|
Brief Pain Inventory (BPI)-Severity Average Pain in the Last Week
|
5.97 units on a scale
STANDARD_DEVIATION 1.70 • n=93 Participants
|
5.86 units on a scale
STANDARD_DEVIATION 1.64 • n=4 Participants
|
5.91 units on a scale
STANDARD_DEVIATION 1.67 • n=27 Participants
|
|
Clinical Global Impression of Severity (CGI-S)
|
4.76 units on a scale
STANDARD_DEVIATION 1.22 • n=93 Participants
|
4.66 units on a scale
STANDARD_DEVIATION 1.07 • n=4 Participants
|
4.71 units on a scale
STANDARD_DEVIATION 1.14 • n=27 Participants
|
|
Short Form-McGill Pain Questionnaire (SF-MPQ), Sensory Portion Total Score
|
12.24 units on a scale
STANDARD_DEVIATION 6.39 • n=93 Participants
|
11.81 units on a scale
STANDARD_DEVIATION 5.52 • n=4 Participants
|
12.02 units on a scale
STANDARD_DEVIATION 5.97 • n=27 Participants
|
|
BPI-Interference Average Score
|
4.38 units on a scale
STANDARD_DEVIATION 2.29 • n=93 Participants
|
4.08 units on a scale
STANDARD_DEVIATION 2.30 • n=4 Participants
|
4.23 units on a scale
STANDARD_DEVIATION 2.30 • n=27 Participants
|
|
Sheehan Disability Scale (SDS) Total Score
|
11.16 units on a scale
STANDARD_DEVIATION 7.59 • n=93 Participants
|
10.54 units on a scale
STANDARD_DEVIATION 7.31 • n=4 Participants
|
10.85 units on a scale
STANDARD_DEVIATION 7.45 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.
24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=172 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=173 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
|
-2.40 units on a scale
Standard Error 0.14
|
-1.97 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.
24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=172 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=173 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain
Night Pain
|
-2.65 units on a scale
Standard Error 0.15
|
-2.11 units on a scale
Standard Error 0.15
|
|
Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain
Worst Pain
|
-2.80 units on a scale
Standard Error 0.16
|
-2.25 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.
BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=175 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=173 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale
|
-2.50 units on a scale
Standard Error 0.15
|
-2.00 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.
CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=108 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=118 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale
|
-1.40 units on a scale
Standard Error 0.10
|
-1.17 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants with a baseline and 12-week PGI-I score.
PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=173 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=176 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint
|
2.44 units on a scale
Standard Error 0.07
|
2.65 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).
SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.
Outcome measures
| Measure |
Duloxetine
n=188 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=180 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ
|
-6.45 units on a scale
Standard Error 0.36
|
-5.33 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with a baseline and postbaseline 24-hour average pain score.
24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% \[or 50% or 75%\] reduction in average daily pain) divided by (number of participants) multiplied by 100.
Outcome measures
| Measure |
Duloxetine
n=200 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=198 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain
≥30% Reduction
|
61.5 percentage of participants
|
49.0 percentage of participants
|
|
Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain
≥50% Reduction
|
42.0 percentage of participants
|
28.8 percentage of participants
|
|
Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain
≥75% Reduction
|
14.5 percentage of participants
|
9.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with a baseline and postbaseline BPI-Severity average pain scores.
BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% \[or 50% or 75%\] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.
Outcome measures
| Measure |
Duloxetine
n=200 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=197 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score
≥30% Reduction
|
63.0 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score
≥50% Reduction
|
46.0 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score
≥75% Reduction
|
15.0 percentage of participants
|
9.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with non-missing BPI-Interference score at baseline and 12 weeks.
BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=173 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=176 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score
|
-2.42 units on a scale
Standard Error 0.13
|
-1.82 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All participants with non-missing SDS Total Score at baseline and 12 weeks.
SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
Duloxetine
n=172 Participants
30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
|
Placebo
n=175 Participants
Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
|
|---|---|---|
|
Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score
|
-6.36 units on a scale
Standard Error 0.40
|
-5.09 units on a scale
Standard Error 0.42
|
Adverse Events
Duloxetine Treatment
Serious events: 4 serious events
Other events: 93 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
Duloxetine Taper
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Taper
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine Treatment
n=202 participants at risk
30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
|
Placebo Treatment
n=202 participants at risk
Placebo administered orally, QD for 12 weeks of the treatment.
|
Duloxetine Taper
n=181 participants at risk
After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
|
Placebo Taper
n=177 participants at risk
After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Cardiac disorders
Nodal arrhythmia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Asthenia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.56%
1/177 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/202
|
0.00%
0/202
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Nervous system disorders
Diabetic neuropathy
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
1.1%
2/181 • Number of events 2
|
0.00%
0/177
|
Other adverse events
| Measure |
Duloxetine Treatment
n=202 participants at risk
30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
|
Placebo Treatment
n=202 participants at risk
Placebo administered orally, QD for 12 weeks of the treatment.
|
Duloxetine Taper
n=181 participants at risk
After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
|
Placebo Taper
n=177 participants at risk
After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
|
|---|---|---|---|---|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/91 • Number of events 1
|
0.00%
0/91
|
0.00%
0/85
|
0.00%
0/76
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
1/202 • Number of events 1
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/202
|
0.00%
0/202
|
0.00%
0/181
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Poor quality sleep
|
1.5%
3/202 • Number of events 3
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Sciatica
|
0.00%
0/202
|
0.00%
0/202
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Nervous system disorders
Somnolence
|
8.4%
17/202 • Number of events 18
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Tremor
|
1.5%
3/202 • Number of events 3
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Agitation
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Fear
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Food aversion
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Illusion
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Insomnia
|
1.5%
3/202 • Number of events 3
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Mutism
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Nervousness
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/202
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Panic attack
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.50%
1/202 • Number of events 2
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.0%
8/202 • Number of events 8
|
1.5%
3/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.99%
2/202 • Number of events 2
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.99%
2/202 • Number of events 2
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Vascular disorders
Hypertension
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Sleep disorder
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Psychiatric disorders
Tic
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Dysuria
|
2.0%
4/202 • Number of events 4
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Pollakiuria
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Renal failure chronic
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Urinary retention
|
0.50%
1/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Renal and urinary disorders
Urine flow decreased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.56%
1/177 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/202
|
0.00%
0/202
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Cardiac disorders
Palpitations
|
2.5%
5/202 • Number of events 5
|
2.0%
4/202 • Number of events 4
|
0.00%
0/181
|
0.00%
0/177
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Ear and labyrinth disorders
Tinnitus
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Ear and labyrinth disorders
Vertigo
|
0.99%
2/202 • Number of events 2
|
1.5%
3/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Eye disorders
Amaurosis
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Eye disorders
Photophobia
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Eye disorders
Vision blurred
|
1.5%
3/202 • Number of events 3
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Eye disorders
Visual impairment
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.5%
7/202 • Number of events 7
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/202 • Number of events 1
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
2/202 • Number of events 2
|
1.5%
3/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
3/202 • Number of events 3
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Constipation
|
5.0%
10/202 • Number of events 10
|
2.0%
4/202 • Number of events 4
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
2/202 • Number of events 2
|
1.5%
3/202 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
5/202 • Number of events 5
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/202 • Number of events 5
|
2.0%
4/202 • Number of events 4
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Eructation
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Faeces hard
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/202
|
0.00%
0/202
|
0.00%
0/181
|
0.56%
1/177 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Nausea
|
10.4%
21/202 • Number of events 23
|
3.5%
7/202 • Number of events 7
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/202
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/202 • Number of events 3
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Asthenia
|
4.5%
9/202 • Number of events 10
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Chest discomfort
|
0.00%
0/202
|
2.0%
4/202 • Number of events 4
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Chest pain
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Chills
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Fatigue
|
5.0%
10/202 • Number of events 10
|
2.0%
4/202 • Number of events 6
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Hunger
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Malaise
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Oedema peripheral
|
0.99%
2/202 • Number of events 2
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Sluggishness
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
General disorders
Thirst
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.99%
2/202 • Number of events 2
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.56%
1/177 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Hepatobiliary disorders
Liver injury
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Infections and infestations
Influenza
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
4/202 • Number of events 4
|
0.99%
2/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/202 • Number of events 1
|
1.5%
3/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/202
|
1.5%
3/202 • Number of events 3
|
0.00%
0/181
|
0.00%
0/177
|
|
Injury, poisoning and procedural complications
Head injury
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Injury, poisoning and procedural complications
Spinal cord injury cauda equina
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/202
|
0.00%
0/202
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Investigations
Blood bicarbonate decreased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood cholesterol decreased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood creatine phosphokinase increased
|
0.99%
2/202 • Number of events 2
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood potassium decreased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood potassium increased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood pressure increased
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Blood uric acid increased
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.99%
2/202 • Number of events 2
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Transaminases increased
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
Weight increased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Investigations
White blood cell count decreased
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.4%
11/202 • Number of events 11
|
4.0%
8/202 • Number of events 8
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.50%
1/202 • Number of events 1
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.99%
2/202 • Number of events 2
|
0.99%
2/202 • Number of events 2
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.5%
9/202 • Number of events 9
|
2.5%
5/202 • Number of events 5
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.5%
3/202 • Number of events 3
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
1.1%
2/181 • Number of events 2
|
0.56%
1/177 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/202 • Number of events 2
|
1.5%
3/202 • Number of events 3
|
0.55%
1/181 • Number of events 1
|
0.00%
0/177
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Autonomic neuropathy
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Cerebral infarction
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Clonus
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Convulsion
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Diabetic autonomic neuropathy
|
0.50%
1/202 • Number of events 1
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Disturbance in attention
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Dizziness
|
8.4%
17/202 • Number of events 18
|
4.5%
9/202 • Number of events 9
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Dreamy state
|
0.50%
1/202 • Number of events 1
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Dysgeusia
|
0.99%
2/202 • Number of events 2
|
0.00%
0/202
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Formication
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Headache
|
3.0%
6/202 • Number of events 6
|
1.5%
3/202 • Number of events 4
|
0.55%
1/181 • Number of events 1
|
0.56%
1/177 • Number of events 1
|
|
Nervous system disorders
Hypersomnia
|
0.99%
2/202 • Number of events 2
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/202
|
0.50%
1/202 • Number of events 1
|
0.00%
0/181
|
0.00%
0/177
|
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