Trial Outcomes & Findings for A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder (NCT NCT01173601)
NCT ID: NCT01173601
Last Updated: 2018-04-17
Results Overview
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 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 calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1416 participants
Primary outcome timeframe
Randomization, 8 weeks
Results posted on
2018-04-17
Participant Flow
The first 3 weeks was a double-blind adjunctive placebo lead-in Confirmation Phase during which participants continued their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to receive LY2216684 12 mg, 18 mg, or placebo. If criteria were not met, participants continued on placebo to maintain the blind.
Participant milestones
| Measure |
Placebo + SSRI (Pre-Randomized Participants)
Placebo: Administered orally, once daily for 3 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
|
12 mg LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
18 mg LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Non-Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks
|
|---|---|---|---|---|---|
|
Confirmation (CF) Phase, 3 Weeks
STARTED
|
1416
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Entered Discontinuation Phase
|
21
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
COMPLETED
|
1328
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
NOT COMPLETED
|
88
|
0
|
0
|
0
|
0
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
STARTED
|
0
|
231
|
230
|
240
|
627
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Entered Taper Discontinuation Phase
|
0
|
100
|
107
|
0
|
0
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Entered Abrupt Discontinuation Phase
|
0
|
100
|
108
|
221
|
586
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
COMPLETED
|
0
|
196
|
197
|
210
|
559
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
NOT COMPLETED
|
0
|
35
|
33
|
30
|
68
|
Reasons for withdrawal
| Measure |
Placebo + SSRI (Pre-Randomized Participants)
Placebo: Administered orally, once daily for 3 weeks, adjunctive to selective serotonin reuptake inhibitor (SSRI)
|
12 mg LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
18 mg LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Non-Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks
|
|---|---|---|---|---|---|
|
Confirmation (CF) Phase, 3 Weeks
Adverse Event
|
23
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Lack of Efficacy
|
9
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Lost to Follow-up
|
7
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Physician Decision
|
3
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Protocol Violation
|
15
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Withdrawal by Subject
|
25
|
0
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Sponsor Decision
|
6
|
0
|
0
|
0
|
0
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Adverse Event
|
0
|
10
|
15
|
7
|
14
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Lack of Efficacy
|
0
|
10
|
6
|
8
|
9
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Lost to Follow-up
|
0
|
3
|
0
|
2
|
9
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Physician Decision
|
0
|
2
|
0
|
2
|
1
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Protocol Violation
|
0
|
1
|
5
|
4
|
5
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Withdrawal by Subject
|
0
|
9
|
7
|
5
|
24
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Sponsor Decision
|
0
|
0
|
0
|
2
|
6
|
Baseline Characteristics
A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
12 mg LY2216684 + SSRI (Randomized Participants)
n=231 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI (Randomized Participants)
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Randomized Participants)
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
Placebo + SSRI (Non-Randomized Participants)
n=627 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
Total
n=1328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.95 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
46.06 years
STANDARD_DEVIATION 12.82 • n=7 Participants
|
44.38 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
44.73 years
STANDARD_DEVIATION 11.89 • n=4 Participants
|
44.94 years
STANDARD_DEVIATION 11.92 • n=21 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
451 Participants
n=4 Participants
|
900 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
428 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
520 Participants
n=4 Participants
|
1061 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
269 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
429 Participants
n=4 Participants
|
927 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
73 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
541 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Region of Enrollment
Russia
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
261 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 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 calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-8.47 units on a scale
Standard Error 0.52
|
-8.70 units on a scale
Standard Error 0.53
|
-7.77 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Function Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Scale
|
-5.36 units on a scale
Standard Error 0.44
|
-5.27 units on a scale
Standard Error 0.44
|
-4.47 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=221 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score
|
-0.74 units on a scale
Standard Error 0.06
|
-0.66 units on a scale
Standard Error 0.06
|
-0.53 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Randomization up to 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 up to Week 8
|
27.83 percentage of participants
|
26.96 percentage of participants
|
26.67 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization up to 8 weeksPopulation: All randomized participants with a baseline and at least one post-baseline value.
A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement, was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
|
16.96 percentage of participants
|
19.13 percentage of participants
|
19.58 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants with a baseline and at least one post-baseline value.
The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=239 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
|
-1.97 units on a scale
Standard Error 0.22
|
-2.05 units on a scale
Standard Error 0.22
|
-1.85 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Randomization up to 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8
|
30.43 percentage of participants
|
34.35 percentage of participants
|
27.08 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=239 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
|
-3.19 units on a scale
Standard Error 0.26
|
-3.38 units on a scale
Standard Error 0.27
|
-2.76 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness \[apparent\], sadness \[reported\], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 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 calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Lassitude
|
-1.04 units on a scale
Standard Error 0.08
|
-1.12 units on a scale
Standard Error 0.08
|
-0.89 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Suicidal thoughts
|
-0.09 units on a scale
Standard Error 0.03
|
-0.13 units on a scale
Standard Error 0.03
|
-0.15 units on a scale
Standard Error 0.03
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Apparent sadness
|
-1.18 units on a scale
Standard Error 0.08
|
-1.04 units on a scale
Standard Error 0.08
|
-1.01 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reported sadness
|
-1.21 units on a scale
Standard Error 0.08
|
-1.20 units on a scale
Standard Error 0.08
|
-1.00 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Inner tension
|
-0.71 units on a scale
Standard Error 0.07
|
-0.74 units on a scale
Standard Error 0.07
|
-0.65 units on a scale
Standard Error 0.07
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reduced sleep
|
-0.97 units on a scale
Standard Error 0.09
|
-0.94 units on a scale
Standard Error 0.09
|
-0.83 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reduced appetite
|
-0.82 units on a scale
Standard Error 0.08
|
-0.74 units on a scale
Standard Error 0.08
|
-0.75 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Concentration difficulties
|
-0.88 units on a scale
Standard Error 0.08
|
-1.01 units on a scale
Standard Error 0.08
|
-0.94 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Inability to feel
|
-1.05 units on a scale
Standard Error 0.08
|
-1.07 units on a scale
Standard Error 0.08
|
-0.90 units on a scale
Standard Error 0.08
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Pessimistic thoughts
|
-0.77 units on a scale
Standard Error 0.07
|
-0.74 units on a scale
Standard Error 0.07
|
-0.74 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
|
-1.01 units on a scale
Standard Error 0.07
|
-1.08 units on a scale
Standard Error 0.07
|
-0.95 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=221 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Average score
|
-0.69 units on a scale
Standard Error 0.05
|
-0.67 units on a scale
Standard Error 0.05
|
-0.57 units on a scale
Standard Error 0.05
|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Experience score
|
-0.66 units on a scale
Standard Error 0.06
|
-0.67 units on a scale
Standard Error 0.06
|
-0.60 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Work impairment score
|
-1.77 units on a scale
Standard Error 0.19
|
-1.74 units on a scale
Standard Error 0.20
|
-1.44 units on a scale
Standard Error 0.19
|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Social life impairment score
|
-1.85 units on a scale
Standard Error 0.16
|
-1.81 units on a scale
Standard Error 0.16
|
-1.64 units on a scale
Standard Error 0.16
|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Family life impairment score
|
-1.72 units on a scale
Standard Error 0.16
|
-1.71 units on a scale
Standard Error 0.16
|
-1.43 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The Q-LES-Q-SF is a self-administered 16-item questionnaire that measures degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point, Likert scale (1=very poor and 5=very good). The total raw score is the sum of items 1 to 14 and ranges from 14 to 70. The 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 were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
|
10.51 percentage of maximum possible score
Standard Error 0.98
|
9.93 percentage of maximum possible score
Standard Error 0.98
|
8.47 percentage of maximum possible score
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing the worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)
|
12.201 units on a scale
Standard Error 1.218
|
12.762 units on a scale
Standard Error 1.225
|
9.756 units on a scale
Standard Error 1.188
|
SECONDARY outcome
Timeframe: Randomization through 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a 'yes' answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a 'yes' answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as TE if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Percentage of Treatment Emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
TE of suicidal ideation
|
3.91 percentage of participants
|
3.91 percentage of participants
|
3.33 percentage of participants
|
|
Percentage of Treatment Emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
TE of suicidal behavior
|
0.00 percentage of participants
|
0.47 percentage of participants
|
0.44 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 \[extremely\] to 6 \[no/never\]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=220 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=233 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale
|
-1.32 units on a scale
Standard Error 0.26
|
-1.27 units on a scale
Standard Error 0.26
|
-0.79 units on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
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 was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=224 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=222 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=236 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
|
-4.70 units on a scale
Standard Error 0.37
|
-4.41 units on a scale
Standard Error 0.38
|
-3.79 units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Through 8 weeksPopulation: All randomized patients who do not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.
Treatment-emergent adverse events (TEAEs) were events that first occurred or worsened during the treatment phase. CYP2D6 functional phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The percentage of participants who reported the TEAE is presented for each phenotype classification. Only TEAEs for which there was a statistically significant treatment-by-SSRI therapy interaction were included: tinnitus and influenza. A summary of serious and other non-serious adverse events regardless of causality is located in the Report of Adverse Events module.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=144 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=140 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=157 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype
Tinnitus PM
|
0.00 percentage of participants
|
3.61 percentage of participants
|
0.00 percentage of participants
|
|
The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype
Influenza non-PM
|
1.39 percentage of participants
|
0.00 percentage of participants
|
0.64 percentage of participants
|
|
The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype
Tinnitus non-PM
|
0.00 percentage of participants
|
0.00 percentage of participants
|
1.27 percentage of participants
|
|
The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype
Influenza PM
|
0.00 percentage of participants
|
2.41 percentage of participants
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Blood pressure (BP) measurements were collected when the participant was in a sitting position. Three measurements of sitting BP collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Blood Pressure (BP)
Sitting systolic BP
|
2.11 millimeters of mercury (mmHg)
Standard Error 0.57
|
3.18 millimeters of mercury (mmHg)
Standard Error 0.57
|
0.02 millimeters of mercury (mmHg)
Standard Error 0.55
|
|
Change From Randomization to Week 8 in Blood Pressure (BP)
Sitting diastolic BP
|
3.57 millimeters of mercury (mmHg)
Standard Error 0.43
|
4.00 millimeters of mercury (mmHg)
Standard Error 0.43
|
0.66 millimeters of mercury (mmHg)
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Randomization, 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
n=230 Participants
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
n=240 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Change From Randomization to Week 8 in Pulse Rate
|
8.66 beats per minute (bpm)
Standard Error 0.64
|
9.12 beats per minute (bpm)
Standard Error 0.64
|
-1.41 beats per minute (bpm)
Standard Error 0.62
|
SECONDARY outcome
Timeframe: 1 week, 4 weeks, and 8 weeksPopulation: Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetics assessment.
A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.
Outcome measures
| Measure |
12 mg LY2216684 + SSRI
n=442 Participants
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
18 mg LY2216684 + SSRI
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI
|
Placebo + SSRI
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI
|
|---|---|---|---|
|
Pharmacokinetics: Plasma Concentrations of LY2216684
12 mg dose
|
37.8 nanograms per milliliter (ng/mL)
Standard Deviation 20.7
|
—
|
—
|
|
Pharmacokinetics: Plasma Concentrations of LY2216684
18 mg dose
|
55.3 nanograms per milliliter (ng/mL)
Standard Deviation 30.4
|
—
|
—
|
Adverse Events
Placebo + SSRI (Pre-randomized) CF Phase
Serious events: 2 serious events
Other events: 240 other events
Deaths: 0 deaths
12 mg LY2216684 + SSRI (Randomized) AT Phase
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
18 mg LY2216684 + SSRI (Randomized) AT Phase
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo + SSRI (Randomized) AT Phase
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo + SSRI (Non-randomized) AT Phase
Serious events: 5 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo + SSRI (Pre-randomized) Discontinuation Phase
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
12 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
12 mg LY2216684 + SSRI (Taper Discontinuation Phase)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
18 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
18 mg LY2216684 + SSRI (Taper Discontinuation Phase)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo + SSRI (Randomized) Discontinuation Phase
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo + SSRI (Non-randomized) Discontinuation Phase
Serious events: 1 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + SSRI (Pre-randomized) CF Phase
n=1413 participants at risk
Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase.
|
12 mg LY2216684 + SSRI (Randomized) AT Phase
n=231 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
18 mg LY2216684 + SSRI (Randomized) AT Phase
n=230 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Randomized) AT Phase
n=240 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Non-randomized) AT Phase
n=627 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Pre-randomized) Discontinuation Phase
n=20 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
12 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
n=108 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
12 mg LY2216684 + SSRI (Taper Discontinuation Phase)
n=100 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
18 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
n=108 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
18 mg LY2216684 + SSRI (Taper Discontinuation Phase)
n=107 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
Placebo + SSRI (Randomized) Discontinuation Phase
n=221 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
Placebo + SSRI (Non-randomized) Discontinuation Phase
n=585 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all non-randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.43%
1/231 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.07%
1/1413 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.43%
1/231 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.0%
1/100 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.16%
1/627 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.16%
1/627 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Investigations
Blood pressure increased
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.16%
1/627 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.16%
1/627 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.16%
1/627 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.17%
1/585 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
1/1413 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.43%
1/230 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.43%
1/231 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/230 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.42%
1/240 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/107 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1413 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/231 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.43%
1/230 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/627 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.93%
1/107 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
Other adverse events
| Measure |
Placebo + SSRI (Pre-randomized) CF Phase
n=1413 participants at risk
Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Includes all enrolled participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase.
|
12 mg LY2216684 + SSRI (Randomized) AT Phase
n=231 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
18 mg LY2216684 + SSRI (Randomized) AT Phase
n=230 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Randomized) AT Phase
n=240 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Non-randomized) AT Phase
n=627 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all non-randomized participants who did not discontinue for the reason 'Lost to Follow-up' at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.
|
Placebo + SSRI (Pre-randomized) Discontinuation Phase
n=20 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
12 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
n=108 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
12 mg LY2216684 + SSRI (Taper Discontinuation Phase)
n=100 participants at risk
LY2216684: 12 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a SSRI
Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
18 mg LY2216684 + SSRI (Abrupt Discontinuation Phase)
n=108 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
18 mg LY2216684 + SSRI (Taper Discontinuation Phase)
n=107 participants at risk
LY2216684: 12 mg, administered orally, once daily for 1 week, followed by 18 mg, administered orally, once daily for 7 weeks, adjunctive to a SSRI, during the adjunctive treatment phase
Includes all randomized participants who tapered discontinuation of LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
Placebo + SSRI (Randomized) Discontinuation Phase
n=221 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
Placebo + SSRI (Non-randomized) Discontinuation Phase
n=585 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a SSRI, during the adjunctive treatment phase.
Includes all non-randomized participants who discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason 'Lost to Follow-up' at the Discontinuation (DC) Phase visit.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.28%
4/1413 • Number of events 4 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
6.9%
16/231 • Number of events 16 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
10.0%
23/230 • Number of events 24 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/240 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.48%
3/627 • Number of events 4 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/100 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.93%
1/107 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/221 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/585 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
55/1413 • Number of events 57 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
4.8%
11/231 • Number of events 11 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.4%
17/230 • Number of events 21 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.42%
1/240 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.1%
13/627 • Number of events 13 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.9%
2/108 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.0%
1/100 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
4.6%
5/108 • Number of events 7 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.6%
6/107 • Number of events 6 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.8%
4/221 • Number of events 4 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
3.2%
19/585 • Number of events 21 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
43/1413 • Number of events 45 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.8%
18/231 • Number of events 18 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
4.3%
10/230 • Number of events 10 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
6.2%
15/240 • Number of events 15 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.4%
34/627 • Number of events 37 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.8%
3/108 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.0%
2/100 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.8%
3/108 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.9%
2/107 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.0%
11/221 • Number of events 11 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.7%
10/585 • Number of events 10 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Nervous system disorders
Dizziness
|
3.2%
45/1413 • Number of events 48 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
3.5%
8/231 • Number of events 9 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.2%
12/230 • Number of events 13 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.1%
5/240 • Number of events 10 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.1%
13/627 • Number of events 16 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.8%
3/108 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.0%
5/100 • Number of events 5 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.8%
3/108 • Number of events 4 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.5%
8/107 • Number of events 11 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
3.2%
7/221 • Number of events 9 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.8%
34/585 • Number of events 42 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Nervous system disorders
Headache
|
8.2%
116/1413 • Number of events 136 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
9.5%
22/231 • Number of events 28 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.8%
18/230 • Number of events 18 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
5.8%
14/240 • Number of events 16 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
6.2%
39/627 • Number of events 47 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
12.0%
13/108 • Number of events 29 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.0%
7/100 • Number of events 9 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
9.3%
10/108 • Number of events 14 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
9.3%
10/107 • Number of events 18 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
11.8%
26/221 • Number of events 36 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
11.8%
69/585 • Number of events 108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.67%
3/447 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
2.3%
2/86 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.2%
1/81 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/85 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.1%
2/176 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/37 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/41 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/38 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/37 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/81 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/168 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
17/1413 • Number of events 17 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
8.2%
19/231 • Number of events 20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
7.0%
16/230 • Number of events 16 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.83%
2/240 • Number of events 2 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.96%
6/627 • Number of events 6 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/20 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.00%
0/108 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
1.0%
1/100 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.93%
1/108 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
3.7%
4/107 • Number of events 7 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.45%
1/221 • Number of events 1 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
0.51%
3/585 • Number of events 3 • Adverse event data was collected over the 3-week double blind adjunctive placebo lead-in confirmation phase, the 8 week double-blind placebo-controlled adjunctive active treatment phase, and the 2-week discontinuation (DC) phase.
During the 2-week DC phase, participants who received LY2216684 were randomly assigned to either abrupt DC or tapered DC over the 2-week period. Participants who had received placebo either during the adjunctive treatment phase or the lead-in confirmation phase remained on placebo during the 2-week DC phase.
|
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