Trial Outcomes & Findings for A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor (NCT NCT01185340)
NCT ID: NCT01185340
Last Updated: 2018-04-27
Results Overview
The Montgomery-Asberg Depression Rating Scale (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
1056 participants
Primary outcome timeframe
Randomization, 8 weeks
Results posted on
2018-04-27
Participant Flow
The first 3 weeks of the study was a double-blind Confirmation Phase during which participants continued to receive their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to adjunctive LY2216684 or adjunctive 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 a selective serotonin reuptake inhibitor (SSRI)
|
LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Non-randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|---|---|
|
Confirmation (CF) Phase, 3 Weeks
STARTED
|
1056
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Entered Discontinuation (DC) Phase
|
18
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
COMPLETED
|
968
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
NOT COMPLETED
|
88
|
0
|
0
|
0
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
STARTED
|
0
|
230
|
219
|
519
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Entered Discontinuation (DC) Phase
|
0
|
206
|
204
|
483
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
COMPLETED
|
0
|
195
|
186
|
458
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
NOT COMPLETED
|
0
|
35
|
33
|
61
|
Reasons for withdrawal
| Measure |
Placebo + SSRI (Pre-randomized Participants)
Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
LY2216684 + SSRI (Randomized Participants)
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Non-randomized Participants)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|---|---|
|
Confirmation (CF) Phase, 3 Weeks
Adverse Event
|
24
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Lack of Efficacy
|
6
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Lost to Follow-up
|
5
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Physician Decision
|
2
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Protocol Violation
|
16
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Withdrawal by Subject
|
32
|
0
|
0
|
0
|
|
Confirmation (CF) Phase, 3 Weeks
Sponsor Decision
|
3
|
0
|
0
|
0
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Adverse Event
|
0
|
13
|
8
|
13
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Lack of Efficacy
|
0
|
4
|
7
|
4
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Lost to Follow-up
|
0
|
4
|
5
|
7
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Physician Decision
|
0
|
1
|
0
|
1
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Protocol Violation
|
0
|
5
|
2
|
5
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Withdrawal by Subject
|
0
|
8
|
8
|
24
|
|
Adjunctive Treatment (AT) Phase, 8 Weeks
Sponsor Decision
|
0
|
0
|
3
|
7
|
Baseline Characteristics
A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor
Baseline characteristics by cohort
| Measure |
LY2216684 + SSRI (Randomized Participants)
n=230 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Randomized Participants)
n=219 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI (Non-randomized Participants)
n=519 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Total
n=968 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.29 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
48.44 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
47.39 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
47.84 years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
654 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
692 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
849 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
58 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
116 Participants
n=4 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 Montgomery-Asberg Depression Rating Scale (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 |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-8.73 units on a scale
Standard Error 0.55
|
-8.49 units on a scale
Standard Error 0.57
|
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 (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 Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater 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 |
LY2216684 + SSRI
n=218 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=208 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score
|
-4.50 units on a scale
Standard Error 0.47
|
-4.38 units on a scale
Standard Error 0.48
|
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 Fatigue Associated with Depression (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. The FAsD impact subscale score ranges from 1 to 5. 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 |
LY2216684 + SSRI
n=218 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=209 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score
|
-0.69 units on a scale
Standard Error 0.06
|
-0.59 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
A Montgomery-Asberg Depression Rating Scale (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). A categorical repeated measures analysis modeled the probability of remission at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.
Outcome measures
| Measure |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8
|
0.313 probability
Standard Error 0.034
|
0.251 probability
Standard Error 0.032
|
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 Montgomery-Asberg Depression Rating Scale (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 |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=218 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
|
20.89 percentage of participants
|
17.89 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 Hospital Anxiety and Depression Scale (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 |
LY2216684 + SSRI
n=224 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
|
-2.20 units on a scale
Standard Error 0.22
|
-1.78 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 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 Montgomery-Asberg Depression Rating Scale (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). A categorical repeated measures analysis modeled the probability of response at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.
Outcome measures
| Measure |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Probability of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
|
0.357 probability
Standard Error 0.034
|
0.352 probability
Standard Error 0.034
|
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 Hospital Anxiety and Depression Scale (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 |
LY2216684 + SSRI
n=224 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in The Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
|
-2.82 units on a scale
Standard Error 0.27
|
-2.64 units on a scale
Standard Error 0.27
|
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 Montgomery-Asberg Depression Rating Scale (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 item score, treatment-by-visit and baseline item score-by-visit.
Outcome measures
| Measure |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Apparent Sadness
|
-1.10 units on a scale
Standard Error 0.09
|
-1.26 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Inner Tension
|
-0.72 units on a scale
Standard Error 0.08
|
-0.71 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reduced Sleep
|
-0.83 units on a scale
Standard Error 0.09
|
-0.76 units on a scale
Standard Error 0.10
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reduced Appetite
|
-0.54 units on a scale
Standard Error 0.08
|
-0.72 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
|
-1.07 units on a scale
Standard Error 0.09
|
-0.82 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Lassitude
|
-1.11 units on a scale
Standard Error 0.09
|
-0.98 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Reported Sadness
|
-1.17 units on a scale
Standard Error 0.09
|
-1.19 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Inability to Feel
|
-1.17 units on a scale
Standard Error 0.09
|
-1.08 units on a scale
Standard Error 0.09
|
|
Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Pessimistic Thoughts
|
-0.88 units on a scale
Standard Error 0.08
|
-0.77 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
|
-0.23 units on a scale
Standard Error 0.05
|
-0.24 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.
Clinical Global Impression - Severity (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 |
LY2216684 + SSRI
n=224 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
|
-1.08 units on a scale
Standard Error 0.08
|
-1.02 units on a scale
Standard Error 0.08
|
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 Fatigue Associated with Depression (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 |
LY2216684 + SSRI
n=217 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=210 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
FAsD experience subscale score
|
-0.57 units on a scale
Standard Error 0.06
|
-0.50 units on a scale
Standard Error 0.06
|
|
Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
FAsD average score
|
-0.62 units on a scale
Standard Error 0.06
|
-0.55 units on a scale
Standard Error 0.06
|
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 |
LY2216684 + SSRI
n=218 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=209 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Work impairment score
|
-1.41 units on a scale
Standard Error 0.22
|
-1.20 units on a scale
Standard Error 0.22
|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Social life impairment score
|
-1.64 units on a scale
Standard Error 0.17
|
-1.53 units on a scale
Standard Error 0.17
|
|
Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Family life impairment score
|
-1.56 units on a scale
Standard Error 0.17
|
-1.53 units on a scale
Standard Error 0.17
|
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 Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a self-administered, 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week 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 |
LY2216684 + SSRI
n=218 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=208 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
|
10.37 percentage of the maximum possible score
Standard Error 1.09
|
9.30 percentage of the maximum possible score
Standard Error 1.12
|
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 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 |
LY2216684 + SSRI
n=216 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=209 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)
|
10.367 units on a scale
Standard Error 1.218
|
9.644 units on a scale
Standard Error 1.252
|
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.
The Columbia-Suicide Severity Rating Scale (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 treatment-emergent (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 |
LY2216684 + SSRI
n=224 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=218 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
TE suicidal ideation
|
4.46 percentage of participants
|
5.96 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
TE suicidal behavior
|
0.00 percentage of participants
|
0.52 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 Arizona Sexual Experiences (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 \[no/never\]) of 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 |
LY2216684 + SSRI
n=214 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=204 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale
|
-0.92 units on a scale
Standard Error 0.25
|
-0.68 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 Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (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. Higher scores indicate greater disease severity. 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 |
LY2216684 + SSRI
n=218 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=210 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
|
-4.12 units on a scale
Standard Error 0.39
|
-3.68 units on a scale
Standard Error 0.40
|
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 measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure 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 |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=217 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Blood Pressure
Systolic blood pressure
|
3.09 millimeters of mercury (mmHg)
Standard Error 0.67
|
0.27 millimeters of mercury (mmHg)
Standard Error 0.69
|
|
Change From Randomization to Week 8 in Blood Pressure
Diastolic blood pressure
|
4.54 millimeters of mercury (mmHg)
Standard Error 0.53
|
0.53 millimeters of mercury (mmHg)
Standard Error 0.54
|
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 |
LY2216684 + SSRI
n=225 Participants
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
Placebo + SSRI
n=216 Participants
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
|
|---|---|---|
|
Change From Randomization to Week 8 in Pulse Rate
|
9.64 beats per minute (bpm)
Standard Error 0.67
|
-1.49 beats per minute (bpm)
Standard Error 0.69
|
Adverse Events
Placebo + SSRI (Pre-randomized) - CF Phase
Serious events: 9 serious events
Other events: 270 other events
Deaths: 0 deaths
LY2216684 + SSRI (Randomized) - AT Phase
Serious events: 7 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo + SSRI (Randomized) - AT Phase
Serious events: 7 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo + SSRI (Non-randomized) - AT Phase
Serious events: 12 serious events
Other events: 128 other events
Deaths: 0 deaths
Placebo + SSRI (Pre-randomized) - DC Phase
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
LY2216684 + SSRI (Randomized) - DC Phase
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo + SSRI (Randomized) - DC Phase
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo + SSRI (Non-randomized) - DC Phase
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + SSRI (Pre-randomized) - CF Phase
n=1052 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.
|
LY2216684 + SSRI (Randomized) - AT Phase
n=228 participants at risk
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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=218 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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=519 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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) - DC Phase
n=18 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
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.
|
LY2216684 + SSRI (Randomized) - DC Phase
n=206 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
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.
|
Placebo + SSRI (Randomized) - DC Phase
n=202 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
Includes all randomized participants who abruptly 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) - DC Phase
n=482 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
Includes all non-randomized participants who abruptly 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
Atrial fibrillation
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.92%
2/218 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.49%
1/206 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.46%
1/218 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Investigations
Blood urea increased
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.46%
1/218 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Sciatica
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Anxiety
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Depression
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.88%
2/228 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.49%
1/206 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Major depression
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.92%
2/218 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.99%
2/202 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Suicide attempt
|
0.10%
1/1052 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.92%
2/218 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.19%
1/519 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
Other adverse events
| Measure |
Placebo + SSRI (Pre-randomized) - CF Phase
n=1052 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.
|
LY2216684 + SSRI (Randomized) - AT Phase
n=228 participants at risk
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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=218 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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=519 participants at risk
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
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) - DC Phase
n=18 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
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.
|
LY2216684 + SSRI (Randomized) - DC Phase
n=206 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
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.
|
Placebo + SSRI (Randomized) - DC Phase
n=202 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
Includes all randomized participants who abruptly 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) - DC Phase
n=482 participants at risk
No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.
Includes all non-randomized participants who abruptly 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
Abdominal discomfort
|
0.57%
6/1052 • Number of events 7 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.88%
2/228 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.39%
2/519 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.49%
1/206 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.41%
2/482 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
33/1052 • Number of events 35 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
3.9%
9/228 • Number of events 9 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.8%
4/218 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.3%
7/519 • Number of events 7 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.97%
2/206 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Nausea
|
5.1%
54/1052 • Number of events 56 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
8.3%
19/228 • Number of events 24 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
3.2%
7/218 • Number of events 9 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
3.1%
16/519 • Number of events 17 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
11.1%
2/18 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.9%
4/206 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
2.5%
5/202 • Number of events 5 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
2.1%
10/482 • Number of events 10 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
7/1052 • Number of events 7 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
6.1%
14/228 • Number of events 16 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.8%
4/218 • Number of events 5 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.3%
7/519 • Number of events 7 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.97%
2/206 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
36/1052 • Number of events 37 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.3%
12/228 • Number of events 13 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.0%
11/218 • Number of events 12 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
6.0%
31/519 • Number of events 31 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.97%
2/206 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.2%
6/482 • Number of events 6 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Dizziness
|
2.7%
28/1052 • Number of events 30 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
6.1%
14/228 • Number of events 14 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
2.8%
6/218 • Number of events 6 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.3%
7/519 • Number of events 7 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.5%
3/206 • Number of events 3 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
2.0%
4/202 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.9%
9/482 • Number of events 9 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Headache
|
11.1%
117/1052 • Number of events 137 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
11.4%
26/228 • Number of events 35 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
6.4%
14/218 • Number of events 17 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
10.2%
53/519 • Number of events 64 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
16.7%
3/18 • Number of events 3 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
13.1%
27/206 • Number of events 30 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
6.9%
14/202 • Number of events 14 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
9.8%
47/482 • Number of events 53 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Somnolence
|
1.0%
11/1052 • Number of events 12 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/228 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.46%
1/218 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.58%
3/519 • Number of events 3 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.41%
2/482 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Tension headache
|
0.19%
2/1052 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.46%
1/218 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.58%
3/519 • Number of events 3 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/482 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Nervous system disorders
Tremor
|
0.38%
4/1052 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.8%
4/228 • Number of events 5 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.77%
4/519 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.97%
2/206 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.83%
4/482 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/1052 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.44%
1/228 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/218 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/519 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
5.6%
1/18 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/206 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/202 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
29/1052 • Number of events 29 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
11.8%
27/228 • Number of events 27 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.92%
2/218 • Number of events 2 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
2.7%
14/519 • Number of events 14 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.00%
0/18 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
1.9%
4/206 • Number of events 4 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.50%
1/202 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
|
0.21%
1/482 • Number of events 1 • Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT 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