Trial Outcomes & Findings for A Study in Adult Patients With Major Depressive Disorder (NCT NCT00795821)
NCT ID: NCT00795821
Last Updated: 2018-03-20
Results Overview
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
495 participants
Primary outcome timeframe
Baseline, Week 10
Results posted on
2018-03-20
Participant Flow
The Screening Phase (Week -1 through Week 0) assessed participant eligibility for not less than 3 days and not more than 30 days. At Week 0, those participants who met entry criteria were randomized in a 1:1 ratio to either LY2216684 (dose range 6 milligram \[mg\] to 18 mg once daily \[QD\]) or placebo.
Participant milestones
| Measure |
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
|---|---|---|
|
Acute Treatment Phase
STARTED
|
250
|
245
|
|
Acute Treatment Phase
COMPLETED
|
194
|
214
|
|
Acute Treatment Phase
NOT COMPLETED
|
56
|
31
|
|
Long-term Extension Phase
STARTED
|
190
|
207
|
|
Long-term Extension Phase
COMPLETED
|
100
|
115
|
|
Long-term Extension Phase
NOT COMPLETED
|
90
|
92
|
|
Taper Phase
STARTED
|
240
|
6
|
|
Taper Phase
COMPLETED
|
231
|
6
|
|
Taper Phase
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
|---|---|---|
|
Acute Treatment Phase
Adverse Event
|
23
|
4
|
|
Acute Treatment Phase
Death
|
1
|
0
|
|
Acute Treatment Phase
Lack of Efficacy
|
5
|
2
|
|
Acute Treatment Phase
Lost to Follow-up
|
9
|
12
|
|
Acute Treatment Phase
Physician Decision
|
1
|
1
|
|
Acute Treatment Phase
Protocol Violation
|
1
|
2
|
|
Acute Treatment Phase
Withdrawal by Subject
|
16
|
10
|
|
Long-term Extension Phase
Adverse Event
|
25
|
32
|
|
Long-term Extension Phase
Lack of Efficacy
|
16
|
12
|
|
Long-term Extension Phase
Lost to Follow-up
|
20
|
16
|
|
Long-term Extension Phase
Physician Decision
|
1
|
2
|
|
Long-term Extension Phase
Protocol Violation
|
3
|
5
|
|
Long-term Extension Phase
Withdrawal by Subject
|
25
|
25
|
|
Taper Phase
Adverse Event
|
2
|
0
|
|
Taper Phase
Lost to Follow-up
|
1
|
0
|
|
Taper Phase
Physician Decision
|
2
|
0
|
|
Taper Phase
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
A Study in Adult Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
LY2216684
n=250 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Placebo
n=245 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Total
n=495 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 11.61 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
200 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
191 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=247 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
|
-13.30 units on a scale
Standard Error 0.563
|
-9.82 units on a scale
Standard Error 0.544
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=202 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=185 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62
|
-7.44 units on a scale
Standard Error 0.674
|
-9.43 units on a scale
Standard Error 0.666
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=241 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=237 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10
|
-8.21 units on a scale
Standard Error 0.499
|
-5.79 units on a scale
Standard Error 0.484
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=179 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=185 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62
|
-3.06 units on a scale
Standard Error 0.654
|
-4.56 units on a scale
Standard Error 0.591
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=247 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10
|
-1.48 units on a scale
Standard Error 0.075
|
-1.08 units on a scale
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=188 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62
|
-1.03 units on a scale
Standard Error 0.087
|
-1.24 units on a scale
Standard Error 0.085
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all participants with a baseline and at least 1 post-baseline value in the Per Protocol population, defined as the subset of randomized participants who had baseline and post-baseline data collected using the correct version of the QIDS-SR16 worksheet.
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=193 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=185 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10
|
-6.50 units on a scale
Standard Error 0.366
|
-4.93 units on a scale
Standard Error 0.360
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=183 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=203 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62
|
-2.64 units on a scale
Standard Error 0.422
|
-3.33 units on a scale
Standard Error 0.399
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=241 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=238 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10
|
-6.61 units on a scale
Standard Error 0.435
|
-5.04 units on a scale
Standard Error 0.437
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=180 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=188 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62
|
-2.79 units on a scale
Standard Error 0.534
|
-3.72 units on a scale
Standard Error 0.480
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=233 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=234 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10
|
0.12 units on a scale
Standard Error 0.011
|
0.09 units on a scale
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=176 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=187 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62
|
0.08 units on a scale
Standard Error 0.015
|
0.06 units on a scale
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=244 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=236 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10
|
-0.99 units on a scale
Standard Error 0.059
|
-0.74 units on a scale
Standard Error 0.057
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=184 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62
|
-0.51 units on a scale
Standard Error 0.076
|
-0.65 units on a scale
Standard Error 0.073
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=247 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=238 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10
|
-0.96 units on a scale
Standard Error 0.060
|
-0.69 units on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=186 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62
|
-0.50 units on a scale
Standard Error 0.080
|
-0.70 units on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=244 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=240 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10
|
-1.02 units on a scale
Standard Error 0.062
|
-0.77 units on a scale
Standard Error 0.060
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=185 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62
|
-0.51 units on a scale
Standard Error 0.078
|
-0.58 units on a scale
Standard Error 0.081
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=241 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=237 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10
|
-2.25 units on a scale
Standard Error 0.147
|
-1.74 units on a scale
Standard Error 0.148
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=180 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=188 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62
|
-1.28 units on a scale
Standard Error 0.202
|
-1.59 units on a scale
Standard Error 0.187
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability \[unable to do any activities\]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=247 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10
Severity of Overall Fatigue
|
-23.30 units on a scale
Standard Error 1.813
|
-16.69 units on a scale
Standard Error 1.757
|
|
Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10
Fatigue Interference With Daily Activities
|
-24.48 units on a scale
Standard Error 1.831
|
-18.62 units on a scale
Standard Error 1.775
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability \[unable to do any activities\]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=187 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=206 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62
Overall Severity of Fatigue
|
-12.72 units on a scale
Standard Error 2.277
|
-18.69 units on a scale
Standard Error 1.990
|
|
Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62
Fatigue Interference With Daily Activities
|
-13.89 units on a scale
Standard Error 2.229
|
-17.47 units on a scale
Standard Error 1.996
|
SECONDARY outcome
Timeframe: Baseline through Week 10Population: The analysis population included all randomized participants.
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
Outcome measures
| Measure |
LY2216684
n=226 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=229 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Percentage of Participants Reporting Resource Utilization at Week 10
Use of Primary Doctor
|
13.3 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 10
Use of Specialist
|
5.8 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 10
Other Diagnostic Tests
|
6.6 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 10
Prescribed Medication
|
34.1 percentage of participants
|
29.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 10) through Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
Outcome measures
| Measure |
LY2216684
n=172 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=180 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Prescribed Medications
|
39.5 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Use of Primary Doctor
|
27.3 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Use of Specialist
|
14.0 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Use of ER or Urgent Care: Other Reason
|
5.8 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Special Scans/Tests
|
5.2 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants Reporting Resource Utilization at Week 62
Other Diagnostic Tests
|
19.2 percentage of participants
|
15.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline C-SSRS value.
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
LY2216684
n=247 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10
Suicidal ideation
|
7.3 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10
Suicidal behavior
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10
Suicidal acts
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 10) through Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
LY2216684
n=188 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62
Suicidal ideation
|
5.9 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62
Suicidal behavior
|
1.1 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62
Suicidal acts
|
0.0 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=246 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10
Supine diastolic
|
3.54 millimeters of mercury (mm Hg)
Standard Error 0.527
|
-0.64 millimeters of mercury (mm Hg)
Standard Error 0.510
|
|
Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10
Supine systolic
|
1.45 millimeters of mercury (mm Hg)
Standard Error 0.708
|
-1.57 millimeters of mercury (mm Hg)
Standard Error 0.683
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=188 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62
Supine systolic
|
0.52 millimeters of mercury (mm Hg)
Standard Error 1.017
|
2.55 millimeters of mercury (mm Hg)
Standard Error 1.064
|
|
Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62
Supine diastolic
|
-0.68 millimeters of mercury (mm Hg)
Standard Error 0.724
|
2.25 millimeters of mercury (mm Hg)
Standard Error 0.710
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=246 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=242 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline in Supine Pulse at Week 10
|
9.72 beats per minute (bpm)
Standard Error 0.677
|
-0.11 beats per minute (bpm)
Standard Error 0.655
|
SECONDARY outcome
Timeframe: Baseline (Week 10), Week 62Population: The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=188 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
n=207 Participants
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Mean Change From Baseline (Week 10) in Supine Pulse at Week 62
|
-1.15 beats per minute (bpm)
Standard Error 0.970
|
7.33 beats per minute (bpm)
Standard Error 0.875
|
SECONDARY outcome
Timeframe: Baseline through Week 62Population: N=number of participants analyzed (N=365); n=number of plasma LY2216684 concentration observations. The sum of the individual 'n' values for each dose group does not equal 365 since the same participant could have received various doses during his/her participation in the study.
Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.
Outcome measures
| Measure |
LY2216684
n=365 Participants
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
6 mg LY2216684
|
12.3 nanograms per milliliter (ng/mL)
Standard Deviation 8.55
|
—
|
|
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
9 mg LY2216684
|
18.2 nanograms per milliliter (ng/mL)
Standard Deviation 13.6
|
—
|
|
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
12 mg LY2216684
|
26.0 nanograms per milliliter (ng/mL)
Standard Deviation 17.3
|
—
|
|
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
18 mg LY2216684
|
40.0 nanograms per milliliter (ng/mL)
Standard Deviation 25.5
|
—
|
Adverse Events
LY2216684 - Acute
Serious events: 2 serious events
Other events: 171 other events
Deaths: 0 deaths
Placebo - Acute
Serious events: 2 serious events
Other events: 133 other events
Deaths: 0 deaths
LY2216684/LY2216684 - Extension
Serious events: 6 serious events
Other events: 126 other events
Deaths: 0 deaths
Placebo/LY2216684 - Extension
Serious events: 5 serious events
Other events: 155 other events
Deaths: 0 deaths
LY2216684 - Taper
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo - Taper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2216684 - Acute
n=250 participants at risk
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo - Acute
n=245 participants at risk
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
LY2216684/LY2216684 - Extension
n=190 participants at risk
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Placebo/LY2216684 - Extension
n=207 participants at risk
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
LY2216684 - Taper
n=240 participants at risk
Participants who took 18 mg LY2216684 received 12 mg QD for 1 week followed by 6 mg QD for 1 week. Participants who took 12 mg, 9 mg, or 6 mg LY2216684 received 6 mg QD for 2 weeks.
|
Placebo - Taper
n=6 participants at risk
Participants who took placebo remained on placebo for 2 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/250
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.62%
1/160 • Number of events 1
|
0.00%
0/143
|
0.00%
0/120
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Major depression
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
Other adverse events
| Measure |
LY2216684 - Acute
n=250 participants at risk
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
|
Placebo - Acute
n=245 participants at risk
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
|
LY2216684/LY2216684 - Extension
n=190 participants at risk
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
Placebo/LY2216684 - Extension
n=207 participants at risk
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
|
LY2216684 - Taper
n=240 participants at risk
Participants who took 18 mg LY2216684 received 12 mg QD for 1 week followed by 6 mg QD for 1 week. Participants who took 12 mg, 9 mg, or 6 mg LY2216684 received 6 mg QD for 2 weeks.
|
Placebo - Taper
n=6 participants at risk
Participants who took placebo remained on placebo for 2 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Measles
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
11/250 • Number of events 11
|
2.9%
7/245 • Number of events 7
|
3.7%
7/190 • Number of events 7
|
8.7%
18/207 • Number of events 18
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Oral herpes
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Otitis media
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Arrhythmia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Palpitations
|
2.4%
6/250 • Number of events 7
|
0.82%
2/245 • Number of events 4
|
1.1%
2/190 • Number of events 2
|
3.9%
8/207 • Number of events 10
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Sinus tachycardia
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Cardiac disorders
Tachycardia
|
4.8%
12/250 • Number of events 13
|
0.82%
2/245 • Number of events 2
|
4.2%
8/190 • Number of events 9
|
8.2%
17/207 • Number of events 21
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Tinnitus
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/250
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Dry eye
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Eye pain
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Eye pruritus
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Eye swelling
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Photophobia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Retinal tear
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
1.2%
3/250 • Number of events 3
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.40%
1/250 • Number of events 1
|
2.0%
5/245 • Number of events 5
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
1.6%
3/190 • Number of events 3
|
2.9%
6/207 • Number of events 7
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
5/250 • Number of events 7
|
1.6%
4/245 • Number of events 5
|
0.53%
1/190 • Number of events 1
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
7.2%
18/250 • Number of events 18
|
2.4%
6/245 • Number of events 6
|
3.2%
6/190 • Number of events 7
|
5.8%
12/207 • Number of events 13
|
0.83%
2/240 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/250 • Number of events 3
|
4.1%
10/245 • Number of events 11
|
1.1%
2/190 • Number of events 2
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dry mouth
|
4.4%
11/250 • Number of events 13
|
3.7%
9/245 • Number of events 9
|
4.2%
8/190 • Number of events 9
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
4/250 • Number of events 5
|
2.0%
5/245 • Number of events 5
|
2.1%
4/190 • Number of events 5
|
1.4%
3/207 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Flatulence
|
0.40%
1/250 • Number of events 1
|
1.2%
3/245 • Number of events 3
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 2
|
0.48%
1/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.40%
1/250 • Number of events 1
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
15.6%
39/250 • Number of events 40
|
4.9%
12/245 • Number of events 14
|
6.8%
13/190 • Number of events 15
|
11.1%
23/207 • Number of events 29
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
0.40%
1/250 • Number of events 1
|
1.2%
3/245 • Number of events 3
|
0.53%
1/190 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
9/250 • Number of events 9
|
0.41%
1/245 • Number of events 2
|
1.6%
3/190 • Number of events 3
|
2.9%
6/207 • Number of events 6
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Asthenia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
1.1%
2/190 • Number of events 3
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Chest discomfort
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Chills
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
1.6%
3/190 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Device leakage
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Fatigue
|
2.8%
7/250 • Number of events 7
|
2.0%
5/245 • Number of events 5
|
0.53%
1/190 • Number of events 1
|
2.4%
5/207 • Number of events 5
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Feeling abnormal
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Feeling cold
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Feeling drunk
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Feeling hot
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Feeling jittery
|
1.2%
3/250 • Number of events 4
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Feeling of body temperature change
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Gait disturbance
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
General physical health deterioration
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Hunger
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Irritability
|
3.6%
9/250 • Number of events 10
|
4.1%
10/245 • Number of events 10
|
1.6%
3/190 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
0.83%
2/240 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Malaise
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Medical device complication
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Oedema peripheral
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Pain
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Sluggishness
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Thirst
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Abscess limb
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Bronchitis
|
0.00%
0/250
|
1.6%
4/245 • Number of events 4
|
1.6%
3/190 • Number of events 3
|
2.9%
6/207 • Number of events 6
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/250
|
0.41%
1/245 • Number of events 2
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Cervicitis
|
0.00%
0/160
|
0.00%
0/143
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Croup infectious
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Cystitis
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Ear infection
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Eye infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Folliculitis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Fungal infection
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/250
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Groin abscess
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Infected bites
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Influenza
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
1.4%
3/207 • Number of events 4
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Pharyngitis
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Pyelonephritis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Respiratory tract infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Rhinitis
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
2.8%
7/250 • Number of events 7
|
1.2%
3/245 • Number of events 3
|
1.1%
2/190 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Streptococcal infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/250
|
0.00%
0/245
|
1.6%
3/190 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Tooth infection
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
6/250 • Number of events 6
|
3.7%
9/245 • Number of events 9
|
5.3%
10/190 • Number of events 12
|
4.8%
10/207 • Number of events 11
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
1.1%
2/190 • Number of events 2
|
1.9%
4/207 • Number of events 4
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/160
|
0.70%
1/143 • Number of events 1
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Infections and infestations
Viral infection
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.62%
1/160 • Number of events 1
|
0.00%
0/143
|
0.00%
0/120
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.62%
1/160 • Number of events 1
|
0.00%
0/143
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/143
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
1.6%
3/190 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Spinal cord injury sacral
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/250
|
0.41%
1/245 • Number of events 2
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
3/250 • Number of events 3
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood pressure diastolic decreased
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood pressure diastolic increased
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood pressure increased
|
4.4%
11/250 • Number of events 11
|
2.9%
7/245 • Number of events 8
|
3.7%
7/190 • Number of events 7
|
3.9%
8/207 • Number of events 8
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Blood pressure orthostatic increased
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Blood pressure systolic increased
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Electrocardiogram QT prolonged
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Heart rate decreased
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Heart rate increased
|
6.4%
16/250 • Number of events 16
|
1.6%
4/245 • Number of events 4
|
4.7%
9/190 • Number of events 9
|
6.3%
13/207 • Number of events 14
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Transaminases increased
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Tuberculin test positive
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
1.2%
3/250 • Number of events 3
|
0.41%
1/245 • Number of events 1
|
2.1%
4/190 • Number of events 4
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Investigations
Weight increased
|
1.6%
4/250 • Number of events 4
|
0.00%
0/245
|
1.6%
3/190 • Number of events 3
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
11/250 • Number of events 11
|
1.2%
3/245 • Number of events 3
|
0.00%
0/190
|
1.9%
4/207 • Number of events 4
|
0.00%
0/240
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
1.4%
3/207 • Number of events 4
|
0.00%
0/240
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.2%
3/250 • Number of events 3
|
1.2%
3/245 • Number of events 3
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.80%
2/250 • Number of events 2
|
1.2%
3/245 • Number of events 3
|
2.6%
5/190 • Number of events 6
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
4/250 • Number of events 4
|
1.2%
3/245 • Number of events 3
|
2.1%
4/190 • Number of events 5
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/250
|
0.41%
1/245 • Number of events 2
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
1.1%
2/190 • Number of events 2
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
2.1%
4/190 • Number of events 4
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.6%
3/190 • Number of events 3
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Amnesia
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Aphasia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Crying
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Disturbance in attention
|
0.40%
1/250 • Number of events 1
|
1.2%
3/245 • Number of events 3
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
6.8%
17/250 • Number of events 18
|
1.2%
3/245 • Number of events 4
|
2.1%
4/190 • Number of events 4
|
4.3%
9/207 • Number of events 10
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness exertional
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness postural
|
1.2%
3/250 • Number of events 3
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Drug withdrawal headache
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Head titubation
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
10.8%
27/250 • Number of events 37
|
9.0%
22/245 • Number of events 28
|
8.4%
16/190 • Number of events 21
|
13.0%
27/207 • Number of events 32
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Hypoaesthesia
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Hypogeusia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Hypokinesia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Lethargy
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
1.6%
3/190 • Number of events 4
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Memory impairment
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Mental impairment
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Migraine
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Paraesthesia
|
1.6%
4/250 • Number of events 4
|
0.41%
1/245 • Number of events 1
|
2.1%
4/190 • Number of events 4
|
1.9%
4/207 • Number of events 6
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Parosmia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Presyncope
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Sciatica
|
0.40%
1/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Sedation
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Sinus headache
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
4.0%
10/250 • Number of events 13
|
2.9%
7/245 • Number of events 7
|
1.6%
3/190 • Number of events 4
|
3.4%
7/207 • Number of events 7
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/250
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Nervous system disorders
Tension headache
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.80%
2/250 • Number of events 3
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/160
|
0.00%
0/143
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Psychiatric disorders
Abnormal dreams
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Aggression
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Agitation
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.97%
2/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.80%
2/250 • Number of events 4
|
2.4%
6/245 • Number of events 7
|
2.6%
5/190 • Number of events 5
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Binge eating
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Blunted affect
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Confusional state
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Emotional disorder
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Initial insomnia
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
1.1%
2/190 • Number of events 2
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
6.4%
16/250 • Number of events 17
|
3.7%
9/245 • Number of events 9
|
4.7%
9/190 • Number of events 9
|
6.8%
14/207 • Number of events 14
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Libido decreased
|
2.8%
7/250 • Number of events 7
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
1.4%
3/207 • Number of events 4
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Middle insomnia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Nicotine dependence
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Nightmare
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Orgasm abnormal
|
1.2%
3/250 • Number of events 3
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Orgasmic sensation decreased
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Panic attack
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Restlessness
|
0.40%
1/250 • Number of events 1
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Sleep disorder
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Suicidal ideation
|
0.80%
2/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Tension
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Terminal insomnia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Psychiatric disorders
Tobacco withdrawal symptoms
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Dysuria
|
1.2%
3/250 • Number of events 3
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
3.4%
7/207 • Number of events 7
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Micturition urgency
|
0.80%
2/250 • Number of events 3
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Pollakiuria
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urethral pain
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary hesitation
|
2.4%
6/250 • Number of events 6
|
0.41%
1/245 • Number of events 1
|
2.6%
5/190 • Number of events 6
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urine flow decreased
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.62%
1/160 • Number of events 1
|
0.00%
0/143
|
0.00%
0/120
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/160
|
0.00%
0/143
|
0.83%
1/120 • Number of events 1
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
2.2%
2/90 • Number of events 2
|
0.00%
0/102
|
1.4%
1/70 • Number of events 1
|
0.00%
0/87
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/90
|
0.00%
0/102
|
0.00%
0/70
|
2.3%
2/87 • Number of events 2
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Epididymitis
|
1.1%
1/90 • Number of events 1
|
0.00%
0/102
|
0.00%
0/70
|
0.00%
0/87
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
9/90 • Number of events 10
|
0.98%
1/102 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
10.3%
9/87 • Number of events 9
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.62%
1/160 • Number of events 1
|
0.00%
0/143
|
0.00%
0/120
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/160
|
0.70%
1/143 • Number of events 1
|
0.00%
0/120
|
0.83%
1/120 • Number of events 1
|
0.00%
0/143
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Penile pain
|
1.1%
1/90 • Number of events 1
|
0.00%
0/102
|
0.00%
0/70
|
0.00%
0/87
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/90
|
0.00%
0/102
|
0.00%
0/70
|
1.1%
1/87 • Number of events 1
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/90
|
0.00%
0/102
|
1.4%
1/70 • Number of events 1
|
0.00%
0/87
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Scrotal pain
|
1.1%
1/90 • Number of events 1
|
0.00%
0/102
|
2.9%
2/70 • Number of events 3
|
0.00%
0/87
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Testicular pain
|
1.1%
1/90 • Number of events 1
|
0.00%
0/102
|
0.00%
0/70
|
1.1%
1/87 • Number of events 1
|
0.00%
0/97
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/160
|
0.70%
1/143 • Number of events 1
|
0.00%
0/120
|
0.00%
0/120
|
0.00%
0/143
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
1/250 • Number of events 2
|
0.00%
0/245
|
0.00%
0/190
|
1.9%
4/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/250 • Number of events 1
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
1.1%
2/190 • Number of events 2
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
1.1%
2/190 • Number of events 3
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/250
|
0.82%
2/245 • Number of events 2
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/250
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
14/250 • Number of events 14
|
1.6%
4/245 • Number of events 4
|
6.3%
12/190 • Number of events 12
|
13.5%
28/207 • Number of events 37
|
0.42%
1/240 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
4/250 • Number of events 4
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.80%
2/250 • Number of events 2
|
0.82%
2/245 • Number of events 2
|
0.00%
0/190
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/245
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Angiopathy
|
0.00%
0/250
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Flushing
|
0.80%
2/250 • Number of events 2
|
0.41%
1/245 • Number of events 1
|
0.53%
1/190 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Hot flush
|
2.0%
5/250 • Number of events 6
|
0.00%
0/245
|
0.53%
1/190 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
2.4%
6/250 • Number of events 6
|
0.82%
2/245 • Number of events 2
|
1.1%
2/190 • Number of events 2
|
2.4%
5/207 • Number of events 5
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
3/250 • Number of events 3
|
0.41%
1/245 • Number of events 1
|
0.00%
0/190
|
0.00%
0/207
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Peripheral coldness
|
2.0%
5/250 • Number of events 5
|
0.82%
2/245 • Number of events 2
|
1.6%
3/190 • Number of events 3
|
1.4%
3/207 • Number of events 3
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Thrombosis
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
|
Vascular disorders
Vasoconstriction
|
0.00%
0/250
|
0.00%
0/245
|
0.00%
0/190
|
0.48%
1/207 • Number of events 1
|
0.00%
0/240
|
0.00%
0/6
|
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