Trial Outcomes & Findings for A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder (NCT NCT00840034)
NCT ID: NCT00840034
Last Updated: 2018-04-24
Results Overview
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.
COMPLETED
PHASE2
227 participants
Baseline, 8 weeks
2018-04-24
Participant Flow
In the Acute Treatment Phase participants are randomized to either LY2216684 or placebo treatment groups. Participants who complete the Acute Treatment Phase or discontinue early after 4 or more weeks in the Acute Treatment phase are eligible to participate in the 2 week Taper Phase, but not all elected to participate.
Participant milestones
| Measure |
LY2216684
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase.
|
Placebo
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Acute Treatment Phase
STARTED
|
111
|
116
|
|
Acute Treatment Phase
COMPLETED
|
90
|
80
|
|
Acute Treatment Phase
NOT COMPLETED
|
21
|
36
|
|
Taper Phase
STARTED
|
90
|
82
|
|
Taper Phase
COMPLETED
|
87
|
80
|
|
Taper Phase
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
LY2216684
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase.
|
Placebo
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Acute Treatment Phase
Adverse Event
|
6
|
8
|
|
Acute Treatment Phase
Lack of Efficacy
|
2
|
0
|
|
Acute Treatment Phase
Lost to Follow-up
|
5
|
12
|
|
Acute Treatment Phase
Physician Decision
|
0
|
1
|
|
Acute Treatment Phase
Protocol Violation
|
2
|
4
|
|
Acute Treatment Phase
Withdrawal by Subject
|
6
|
11
|
|
Taper Phase
Adverse Event
|
1
|
0
|
|
Taper Phase
Lost to Follow-up
|
1
|
1
|
|
Taper Phase
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
LY2216684
n=111 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=116 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MADRS Total Score.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=62 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=68 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)
|
-8.13 units on a scale
Standard Error 1.251
|
-5.76 units on a scale
Standard Error 1.249
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Total Score.
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=63 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=68 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score
|
-4.71 units on a scale
Standard Error 0.625
|
-2.97 units on a scale
Standard Error 0.628
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Individual Score.
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=63 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=68 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Highest Score from Items 1-4
|
-0.49 units on a scale
Standard Error 0.113
|
-0.26 units on a scale
Standard Error 0.115
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 5
|
-0.88 units on a scale
Standard Error 0.124
|
-0.45 units on a scale
Standard Error 0.126
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Highest Score from Items 6-9
|
-0.32 units on a scale
Standard Error 0.131
|
-0.29 units on a scale
Standard Error 0.133
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 10
|
-0.61 units on a scale
Standard Error 0.094
|
-0.33 units on a scale
Standard Error 0.095
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 11
|
-0.77 units on a scale
Standard Error 0.127
|
-0.39 units on a scale
Standard Error 0.129
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 12
|
-0.21 units on a scale
Standard Error 0.048
|
-0.19 units on a scale
Standard Error 0.049
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 13
|
-0.55 units on a scale
Standard Error 0.139
|
-0.48 units on a scale
Standard Error 0.140
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Item 14
|
-0.65 units on a scale
Standard Error 0.109
|
-0.28 units on a scale
Standard Error 0.110
|
|
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Highest Score from Items 15-16
|
-0.53 units on a scale
Standard Error 0.129
|
-0.14 units on a scale
Standard Error 0.130
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline HADS Score; last observation carried forward (LOCF).
HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=61 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=63 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)
Anxiety Subscale Score
|
-2.19 units on a scale
Standard Error 0.484
|
-1.42 units on a scale
Standard Error 0.483
|
|
Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)
Depression Subscale Score
|
-3.28 units on a scale
Standard Error 0.549
|
-1.93 units on a scale
Standard Error 0.551
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CGI-Severity Score.
CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=63 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=68 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)
|
-0.74 units on a scale
Standard Error 0.135
|
-0.71 units on a scale
Standard Error 0.135
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CPFQ Total Score.
The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=63 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=68 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
|
-5.69 units on a scale
Standard Error 0.831
|
-2.62 units on a scale
Standard Error 0.833
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline FAsD-PRO Score; last observation carried forward (LOCF).
The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=58 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=59 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)
Overall Average Score
|
-0.75 units on a scale
Standard Error 0.124
|
-0.41 units on a scale
Standard Error 0.127
|
|
Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)
Fatigue Experience Score
|
-0.60 units on a scale
Standard Error 0.126
|
-0.42 units on a scale
Standard Error 0.129
|
|
Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)
Fatigue Impact Score
|
-0.92 units on a scale
Standard Error 0.140
|
-0.41 units on a scale
Standard Error 0.140
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-F Score; last observation carried forward (LOCF).
VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=59 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=58 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)
Severity
|
-16.42 units on a scale
Standard Error 3.407
|
-13.81 units on a scale
Standard Error 3.412
|
|
Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)
Interference
|
-18.91 units on a scale
Standard Error 3.698
|
-10.33 units on a scale
Standard Error 3.701
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-P Score; last observation carried forward (LOCF).
VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=59 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=58 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)
Severity
|
-4.17 units on a scale
Standard Error 3.450
|
-0.91 units on a scale
Standard Error 3.448
|
|
Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)
Interference
|
-9.56 units on a scale
Standard Error 3.611
|
-0.13 units on a scale
Standard Error 3.613
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline SDS Total Score; last observation carried forward. Missing work score imputed with average of other 2-item scores.
The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=58 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=56 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)
|
-5.95 units on a scale
Standard Error 1.116
|
-2.63 units on a scale
Standard Error 1.123
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; last observation carried forward. If ≤2 items are missing mean of all other items are imputed.
The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=59 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=58 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)
|
12.94 percentage of the maximum possible score
Standard Error 2.073
|
5.44 percentage of the maximum possible score
Standard Error 2.078
|
SECONDARY outcome
Timeframe: Baseline, up to 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MGH-SFQ Score.
The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Outcome measures
| Measure |
LY2216684
n=103 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=104 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Interest
|
-0.70 units on a scale
Standard Error 0.133
|
-0.25 units on a scale
Standard Error 0.136
|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Arousal
|
-0.74 units on a scale
Standard Error 0.130
|
-0.27 units on a scale
Standard Error 0.132
|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Ability to Reach Orgasm
|
-0.81 units on a scale
Standard Error 0.142
|
-0.36 units on a scale
Standard Error 0.144
|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Erectile Function - Males Only
|
-0.30 units on a scale
Standard Error 0.237
|
-0.48 units on a scale
Standard Error 0.233
|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Overall Satisfaction
|
-0.63 units on a scale
Standard Error 0.141
|
-0.48 units on a scale
Standard Error 0.144
|
|
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Overall Improvement
|
3.45 units on a scale
Standard Error 0.119
|
3.62 units on a scale
Standard Error 0.121
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline C-SSRS Score.
Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
LY2216684
n=107 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=109 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Colombia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
11.2 percentage of participants
|
7.3 percentage of participants
|
|
Colombia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0.9 percentage of participants
|
0.0 percentage of participants
|
|
Colombia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Acts
|
0.0 percentage of participants
|
0.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who have baseline and at least 1 post-baseline supine systolic and diastolic blood pressure measure.
Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=107 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=109 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure
Systolic Blood Pressure
|
3.61 millimeters of mercury (mm Hg)
Standard Error 1.131
|
1.31 millimeters of mercury (mm Hg)
Standard Error 1.195
|
|
Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure
|
2.67 millimeters of mercury (mm Hg)
Standard Error 0.730
|
0.77 millimeters of mercury (mm Hg)
Standard Error 0.772
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and included all participants who have baseline and at least 1 post-baseline supine pulse rate measure.
Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Outcome measures
| Measure |
LY2216684
n=107 Participants
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=109 Participants
Placebo: 3 tablets PO QD for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline to 8 Weeks in Supine Pulse
|
6.74 beats per minute (bpm)
Standard Error 0.986
|
0.65 beats per minute (bpm)
Standard Error 1.038
|
Adverse Events
LY2216684
Placebo
LY2216684-Taper Phase
Placebo-Taper Phase
Serious adverse events
| Measure |
LY2216684
n=111 participants at risk
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=116 participants at risk
Placebo: 3 tablets orally, once daily for up to 12 weeks.
|
LY2216684-Taper Phase
n=90 participants at risk
LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks.
|
Placebo-Taper Phase
n=82 participants at risk
Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Haemoglobin decreased
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Paraesthesia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
Other adverse events
| Measure |
LY2216684
n=111 participants at risk
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase.
|
Placebo
n=116 participants at risk
Placebo: 3 tablets orally, once daily for up to 12 weeks.
|
LY2216684-Taper Phase
n=90 participants at risk
LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks.
|
Placebo-Taper Phase
n=82 participants at risk
Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Cardiac disorders
Myocardial ischaemia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Cardiac disorders
Palpitations
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Congenital, familial and genetic disorders
Uterine hypoplasia
|
0.00%
0/79
|
1.3%
1/79 • Number of events 1
|
0.00%
0/63
|
0.00%
0/59
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Eye disorders
Blepharospasm
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Eye disorders
Vision blurred
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Constipation
|
0.90%
1/111 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
1/111 • Number of events 1
|
1.7%
2/116 • Number of events 3
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Dry mouth
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
2/111 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/111
|
0.00%
0/116
|
0.00%
0/90
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Gastrointestinal disorders
Nausea
|
7.2%
8/111 • Number of events 8
|
2.6%
3/116 • Number of events 3
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/111 • Number of events 3
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
General disorders
Chills
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Fatigue
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Feeling cold
|
1.8%
2/111 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Feeling jittery
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Influenza like illness
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
General disorders
Irritability
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Pain
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Pyrexia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Sluggishness
|
0.00%
0/111
|
0.86%
1/116 • Number of events 2
|
0.00%
0/90
|
0.00%
0/82
|
|
General disorders
Thirst
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Infections and infestations
Bronchitis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
1.2%
1/82 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Gastroenteritis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
1.2%
1/82 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Influenza
|
3.6%
4/111 • Number of events 5
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
2/111 • Number of events 2
|
2.6%
3/116 • Number of events 3
|
0.00%
0/90
|
1.2%
1/82 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Parotitis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Sinusitis
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Tooth abscess
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
3/111 • Number of events 3
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
3.7%
3/82 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/111
|
0.86%
1/116 • Number of events 3
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.00%
0/79
|
1.3%
1/79 • Number of events 1
|
0.00%
0/63
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Eye burns
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Blood potassium decreased
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Blood pressure increased
|
1.8%
2/111 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Electrocardiogram qt prolonged
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Heart rate increased
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Neutrophil count increased
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Urine output decreased
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
Weight decreased
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Investigations
White blood cell count increased
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
3/111 • Number of events 3
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
2/111 • Number of events 2
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.90%
1/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Convulsion
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Dizziness
|
4.5%
5/111 • Number of events 6
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Dysgeusia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Headache
|
0.90%
1/111 • Number of events 1
|
3.4%
4/116 • Number of events 6
|
0.00%
0/90
|
1.2%
1/82 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Lethargy
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Memory impairment
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Migraine
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Nerve compression
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Poor quality sleep
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Sinus headache
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Somnolence
|
1.8%
2/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Syncope
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Tension headache
|
0.00%
0/111
|
1.7%
2/116 • Number of events 2
|
0.00%
0/90
|
0.00%
0/82
|
|
Nervous system disorders
Tremor
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Abnormal dreams
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Agitation
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Anxiety
|
2.7%
3/111 • Number of events 3
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Blunted affect
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Dermatillomania
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Initial insomnia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/111
|
3.4%
4/116 • Number of events 4
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Psychiatric disorders
Loss of libido
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Middle insomnia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Psychiatric disorders
Restlessness
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Psychiatric disorders
Sleep attacks
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.90%
1/111 • Number of events 1
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Renal and urinary disorders
Residual urine
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Renal and urinary disorders
Urinary hesitation
|
3.6%
4/111 • Number of events 4
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Renal and urinary disorders
Urinary retention
|
0.90%
1/111 • Number of events 2
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
0.00%
0/27
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
2/32 • Number of events 2
|
0.00%
0/37
|
0.00%
0/27
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/79
|
1.3%
1/79 • Number of events 1
|
0.00%
0/63
|
0.00%
0/59
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Reproductive system and breast disorders
Testicular pain
|
6.2%
2/32 • Number of events 2
|
0.00%
0/37
|
0.00%
0/27
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Testicular swelling
|
3.1%
1/32 • Number of events 1
|
0.00%
0/37
|
0.00%
0/27
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/79
|
1.3%
1/79 • Number of events 1
|
0.00%
0/63
|
0.00%
0/59
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/79
|
1.3%
1/79 • Number of events 1
|
0.00%
0/63
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/111
|
0.00%
0/116
|
1.1%
1/90 • Number of events 1
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/111
|
1.7%
2/116 • Number of events 2
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.2%
8/111 • Number of events 8
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.90%
1/111 • Number of events 1
|
1.7%
2/116 • Number of events 2
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/111
|
0.86%
1/116 • Number of events 1
|
0.00%
0/90
|
0.00%
0/82
|
|
Vascular disorders
Haematoma
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Vascular disorders
Hot flush
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
|
Vascular disorders
Peripheral coldness
|
0.90%
1/111 • Number of events 1
|
0.00%
0/116
|
0.00%
0/90
|
0.00%
0/82
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60