A Study in Adult Patients With Major Depressive Disorder | NCT00795821 | Trialant
NCT00795821
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 20, 2018Actual
Enrollment
495Actual
Phase
Phase 2Phase 3
Conditions
Depressive Disorder, Major
Interventions
LY2216684
Placebo
Countries
United States
Argentina
Finland
Poland
Russia
Protocol Section
Identification Module
NCT ID
NCT00795821
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11313
Secondary IDs
ID
Type
Description
Link
H9P-MC-LNBI
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Adult Patients With Major Depressive Disorder
Official Title
A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Feb 2010Actual
Completion Date
Mar 2011Actual
First Submitted Date
Nov 19, 2008
First Submission Date that Met QC Criteria
Nov 19, 2008
First Posted Date
Nov 21, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 17, 2018
Results First Submitted that Met QC Criteria
Mar 16, 2018
Results First Posted Date
Mar 20, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 28, 2011
Certification/Extension First Submitted that Passed QC Review
Jan 28, 2011
Certification/Extension First Posted Date
Feb 7, 2011Estimated
Last Update Submitted Date
Mar 16, 2018
Last Update Posted Date
Mar 20, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with major depressive disorder.
Detailed Description
Not provided
Conditions Module
Conditions
Depressive Disorder, Major
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
495Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2216684
Experimental
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Drug: LY2216684
Placebo
Placebo Comparator
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2216684
Drug
Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks
LY2216684
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults age 18-65 years
Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria without psychotic features
Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
Grid 17-item Hamilton Rating Scale for Depression (GRID-HAMD17) total score ≥18 at Visit 1 and Visit 2
Clinical global impressions of severity (CGI-S) score ≥4 at Visit 1 and Visit 2
Exclusion Criteria:
Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
Have previously completed or withdrawn from this study or any other study investigating LY2216684
Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of Visit 1
Have an Axis II disorder that would interfere with protocol compliance
Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia, or other psychotic disorder
Have a history of substance abuse within the past 1 year
Women who are pregnant or breast-feeding
Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgment of the investigator, considered to have treatment-resistant depression
Participants who are judged to be at serious suicidal risk
Have a serious or unstable medical illness
Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1
Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
Have a history of any seizure disorder (other than febrile seizures)
Require psychotropic medication other than sedative/hypnotic medication for sleep
Have a thyroid stimulating hormone (TSH) level outside the established reference range.
Are taking or have received treatment with any excluded medication within 7 days prior to Visit 2
Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
A positive urine drug screen for any substance of abuse at Visit 1
Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The Screening Phase (Week -1 through Week 0) assessed participant eligibility for not less than 3 days and not more than 30 days. At Week 0, those participants who met entry criteria were randomized in a 1:1 ratio to either LY2216684 (dose range 6 milligram [mg] to 18 mg once daily [QD]) or placebo.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Baseline, Week 10
Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Baseline, Week 10
Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Percentage of Participants Reporting Resource Utilization at Week 10
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
Baseline through Week 10
Percentage of Participants Reporting Resource Utilization at Week 62
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
Baseline (Week 10) through Week 62
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
Baseline through Week 10
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
Baseline (Week 10) through Week 62
Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Mean Change From Baseline in Supine Pulse at Week 10
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10
Mean Change From Baseline (Week 10) in Supine Pulse at Week 62
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
Baseline (Week 10), Week 62
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.
Baseline through Week 62
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock
Arkansas
72223
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beverly Hills
California
90210
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cerritos
California
90703
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver
Colorado
80239
United States
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Hamden
Connecticut
06518
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North Miami
Florida
33161
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orlando
Florida
32806
United States
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West Palm Beach
Florida
33407
United States
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Atlanta
Georgia
30328
United States
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Smyrna
Georgia
30080
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Overland Park
Kansas
66212
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baltimore
Maryland
21208
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Willingboro
New Jersey
08046
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albuquerque
New Mexico
87109
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Portland
Oregon
97210
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis
Tennessee
38119
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Antonio
Texas
78229
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bellevue
Washington
98007
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires
C1425AHQ
Argentina
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La Plata
1900
Argentina
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Helsinki
00530
Finland
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Oulu
90100
Finland
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Tampere
33100
Finland
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Turku
20100
Finland
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Bełchatów
97-400
Poland
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Bialystok
18-879
Poland
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Gdansk
80 282
Poland
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Gorlice
38-300
Poland
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Leszno
64-100
Poland
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Lublin
20-015
Poland
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Torun
87-100
Poland
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Tuszyn
95-080
Poland
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Kazan'
420012
Russia
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Rostov-on-Don
344010
Russia
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Saint Petersburg
191025
Russia
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Tomsk
634014
Russia
FG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
FG000250 subjects
FG001245 subjects
COMPLETED
FG000194 subjects4 LY-treated participants in the Acute Phase chose not to enter the Long-term Extension Phase.
FG001214 subjects7 placebo-treated participants in the Acute Phase chose not to enter the Long-term Extension Phase.
NOT COMPLETED
FG00056 subjects
FG00131 subjects
Type
Comment
Reasons
Adverse Event
FG00023 subjects
FG0014 subjects
Death
FG0001 subjects
FG0010 subjects
Lack of Efficacy
FG0005 subjects
FG0012 subjects
Lost to Follow-up
FG0009 subjects
FG00112 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
Withdrawal by Subject
FG00016 subjects
FG00110 subjects
Long-term Extension Phase
Type
Comment
Milestone Data
STARTED
FG000190 subjects
FG001207 subjectsAll placebo-treated participants received LY2216684 in the Long-term Extension Phase.
COMPLETED
FG000100 subjects
FG001115 subjects
NOT COMPLETED
FG00090 subjects
FG00192 subjects
Type
Comment
Reasons
Adverse Event
FG00025 subjects
FG00132 subjects
Lack of Efficacy
FG00016 subjects
FG001
Taper Phase
Type
Comment
Milestone Data
STARTED
FG000240 subjectsN=240 participants entered Taper Phases: N=4 from Acute Phase; N=236 from Extension Phase.
FG0016 subjectsN=6 participants entered only Acute Taper Phase.
COMPLETED
FG000231 subjectsN=231 participants completed Taper Phases: N=3 from Acute Phase; N=228 from Extension Phase.
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
BG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000250
BG001245
BG002495
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.2± 11.32
BG00145.5± 11.61
BG00244.8± 11.47
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000160
BG001143
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00031
BG00125
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0013
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG000140
BG001135
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Participants
OG000247
OG001242
Title
Denominators
Categories
Title
Measurements
OG000-13.30± 0.563
OG001-9.82± 0.544
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
<0.001
Superiority or Other
Secondary
Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Secondary
Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62
The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Participants
Secondary
Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62
CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all participants with a baseline and at least 1 post-baseline value in the Per Protocol population, defined as the subset of randomized participants who had baseline and post-baseline data collected using the correct version of the QIDS-SR16 worksheet.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Secondary
Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62
The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Secondary
Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62
The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62
EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62
The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62
The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its "worst," "usual," and "now" during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant's life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62
The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Percentage of Participants Reporting Resource Utilization at Week 10
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
The analysis population included all randomized participants.
Posted
Number
percentage of participants
Baseline through Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Reporting Resource Utilization at Week 62
The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Number
percentage of participants
Baseline (Week 10) through Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline C-SSRS value.
Posted
Number
percentage of participants
Baseline through Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Secondary
Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62
C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a "yes" answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a "yes" answer to actual attempt or completed suicide.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Number
percentage of participants
Baseline (Week 10) through Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Secondary
Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
millimeters of mercury (mm Hg)
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Participants
Secondary
Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62
Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
millimeters of mercury (mm Hg)
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Units
Secondary
Mean Change From Baseline in Supine Pulse at Week 10
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline, Week 10
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
OG001
Placebo
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline (Week 10) in Supine Pulse at Week 62
Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.
The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
beats per minute (bpm)
Baseline (Week 10), Week 62
ID
Title
Description
OG000
LY2216684/LY2216684
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
OG001
Placebo/LY2216684
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Units
Counts
Secondary
Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684
Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.
N=number of participants analyzed (N=365); n=number of plasma LY2216684 concentration observations. The sum of the individual 'n' values for each dose group does not equal 365 since the same participant could have received various doses during his/her participation in the study.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Baseline through Week 62
ID
Title
Description
OG000
LY2216684
10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase, or 6 mg LY2216684 dose if participants were taking placebo; After Week 1=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
Units
Counts
Participants
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LY2216684 - Acute
10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
2
250
171
250
EG001
Placebo - Acute
10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
2
245
133
245
EG002
LY2216684/LY2216684 - Extension
1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
6
190
126
190
EG003
Placebo/LY2216684 - Extension
1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
5
207
155
207
EG004
LY2216684 - Taper
Participants who took 18 mg LY2216684 received 12 mg QD for 1 week followed by 6 mg QD for 1 week. Participants who took 12 mg, 9 mg, or 6 mg LY2216684 received 6 mg QD for 2 weeks.
0
240
15
240
EG005
Placebo - Taper
Participants who took placebo remained on placebo for 2 weeks.
0
6
0
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG0030 events0 affected207 at risk
EG0040 events0 affected240 at risk
EG0050 events0 affected6 at risk
Tachycardia paroxysmal
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Ruptured cerebral aneurysm
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected160 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected120 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Schizoaffective disorder
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG0031 events1 affected207 at risk
EG0040 events0 affected240 at risk
EG0050 events0 affected6 at risk
Macrocytosis
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Normochromic normocytic anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Aortic valve sclerosis
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Cardiac flutter
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Left atrial dilatation
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0007 events6 affected250 at risk
EG0014 events2 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG00013 events12 affected250 at risk
EG0012 events2 affected245 at risk
EG0029 events8 affected190 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Dry eye
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Eye pain
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Eye swelling
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Photophobia
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Retinal tear
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0015 events5 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0007 events5 affected250 at risk
EG0015 events4 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Bowel movement irregularity
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00018 events18 affected250 at risk
EG0016 events6 affected245 at risk
EG0027 events6 affected190 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected250 at risk
EG00111 events10 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00013 events11 affected250 at risk
EG0019 events9 affected245 at risk
EG0029 events8 affected190 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0005 events4 affected250 at risk
EG0015 events5 affected245 at risk
EG0025 events4 affected190 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0013 events3 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events1 affected190 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00040 events39 affected250 at risk
EG00114 events12 affected245 at risk
EG00215 events13 affected190 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0013 events3 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0009 events9 affected250 at risk
EG0012 events1 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Asthenia
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0023 events2 affected190 at risk
EG003
Chest discomfort
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Chills
General disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0010 events0 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Device leakage
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Systematic Assessment
EG0007 events7 affected250 at risk
EG0015 events5 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Feeling abnormal
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Feeling cold
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Feeling drunk
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Feeling hot
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Feeling jittery
General disorders
MedDRA 13.1
Systematic Assessment
EG0004 events3 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Gait disturbance
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
General physical health deterioration
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Hunger
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Irritability
General disorders
MedDRA 13.1
Systematic Assessment
EG00010 events9 affected250 at risk
EG00110 events10 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Malaise
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Medical device complication
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Sluggishness
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Thirst
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0014 events4 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected160 at risk
EG0010 events0 affected143 at risk
EG0021 events1 affected120 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Ear infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Eye infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Infected bites
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Measles
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00011 events11 affected250 at risk
EG0017 events7 affected245 at risk
EG0027 events7 affected190 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Otitis media
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0007 events7 affected250 at risk
EG0013 events3 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0006 events6 affected250 at risk
EG0019 events9 affected245 at risk
EG00212 events10 affected190 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected160 at risk
EG0011 events1 affected143 at risk
EG0021 events1 affected120 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected160 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected120 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Drug exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected160 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected120 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Spinal cord injury sacral
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Bleeding time prolonged
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Blood pressure diastolic decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Blood pressure increased
Investigations
MedDRA 13.1
Systematic Assessment
EG00011 events11 affected250 at risk
EG0018 events7 affected245 at risk
EG0027 events7 affected190 at risk
EG003
Blood pressure orthostatic decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Blood pressure orthostatic increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Heart rate decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Heart rate increased
Investigations
MedDRA 13.1
Systematic Assessment
EG00016 events16 affected250 at risk
EG0014 events4 affected245 at risk
EG0029 events9 affected190 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Transaminases increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Tuberculin test positive
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Weight decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected250 at risk
EG0011 events1 affected245 at risk
EG0024 events4 affected190 at risk
EG003
Weight increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0004 events4 affected250 at risk
EG0010 events0 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG00011 events11 affected250 at risk
EG0013 events3 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected250 at risk
EG0013 events3 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0013 events3 affected245 at risk
EG0026 events5 affected190 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0004 events4 affected250 at risk
EG0013 events3 affected245 at risk
EG0025 events4 affected190 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Joint crepitation
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected190 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected250 at risk
EG0011 events1 affected245 at risk
EG0024 events4 affected190 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0011 events1 affected245 at risk
EG0023 events3 affected190 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected190 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected250 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected190 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
<0.001
To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.
95
Superiority or Other
Units
Counts
Participants
OG000179
OG001185
Title
Denominators
Categories
Title
Measurements
OG000-3.06± 0.654
OG001-4.56± 0.591
OG000247
OG001242
Title
Denominators
Categories
Title
Measurements
OG000-1.48± 0.075
OG001-1.08± 0.072
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
<0.001
95
Superiority or Other
Units
Counts
Participants
OG000188
OG001207
Title
Denominators
Categories
Title
Measurements
OG000-1.03± 0.087
OG001-1.24± 0.085
Counts
Participants
OG000193
OG001185
Title
Denominators
Categories
Title
Measurements
OG000-6.50± 0.366
OG001-4.93± 0.360
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.002
95
Superiority or Other
Units
Counts
Participants
OG000183
OG001203
Title
Denominators
Categories
Title
Measurements
OG000-2.64± 0.422
OG001-3.33± 0.399
Participants
OG000241
OG001238
Title
Denominators
Categories
Title
Measurements
OG000-6.61± 0.435
OG001-5.04± 0.437
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Model terms included treatment, investigator, and baseline score.
0.007
95
Superiority or Other
Units
Counts
Participants
OG000180
OG001188
Title
Denominators
Categories
Title
Measurements
OG000-2.79± 0.534
OG001-3.72± 0.480
Units
Counts
Participants
OG000233
OG001234
Title
Denominators
Categories
Title
Measurements
OG0000.12± 0.011
OG0010.09± 0.011
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Model terms included treatment, investigator, and baseline score.
0.056
95
Superiority or Other
Units
Counts
Participants
OG000176
OG001187
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.015
OG0010.06± 0.014
Units
Counts
Participants
OG000244
OG001236
Title
Denominators
Categories
Title
Measurements
OG000-0.99± 0.059
OG001-0.74± 0.057
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.002
95
Superiority or Other
Units
Counts
Participants
OG000184
OG001207
Title
Denominators
Categories
Title
Measurements
OG000-0.51± 0.076
OG001-0.65± 0.073
Units
Counts
Participants
OG000247
OG001238
Title
Denominators
Categories
Title
Measurements
OG000-0.96± 0.060
OG001-0.69± 0.058
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
<0.001
95
Superiority or Other
Units
Counts
Participants
OG000186
OG001207
Title
Denominators
Categories
Title
Measurements
OG000-0.50± 0.080
OG001-0.70± 0.078
Units
Counts
Participants
OG000244
OG001240
Title
Denominators
Categories
Title
Measurements
OG000-1.02± 0.062
OG001-0.77± 0.060
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.003
95
Superiority or Other
Units
Counts
Participants
OG000185
OG001207
Title
Denominators
Categories
Title
Measurements
OG000-0.51± 0.078
OG001-0.58± 0.081
Units
Counts
Participants
OG000241
OG001237
Title
Denominators
Categories
Title
Measurements
OG000-2.25± 0.147
OG001-1.74± 0.148
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Model terms included treatment, investigator, and baseline score.
0.009
95
Superiority or Other
Units
Counts
Participants
OG000180
OG001188
Title
Denominators
Categories
Title
Measurements
OG000-1.28± 0.202
OG001-1.59± 0.187
Units
Counts
Participants
OG000247
OG001242
Title
Denominators
Categories
Severity of Overall Fatigue
Title
Measurements
OG000-23.30± 1.813
OG001-16.69± 1.757
Fatigue Interference With Daily Activities
Title
Measurements
OG000-24.48± 1.831
OG001-18.62± 1.775
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.008
P-value for Severity of Overall Fatigue
95
Superiority or Other
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.024
P-value for Fatigue Interference with Daily Activities
95
Superiority or Other
Units
Counts
Participants
OG000187
OG001206
Title
Denominators
Categories
Overall Severity of Fatigue
Title
Measurements
OG000-12.72± 2.277
OG001-18.69± 1.990
Fatigue Interference With Daily Activities
Title
Measurements
OG000-13.89± 2.229
OG001-17.47± 1.996
226
OG001229
Title
Denominators
Categories
Use of Primary Doctor
Title
Measurements
OG00013.3
OG00110.9
Use of Specialist
Title
Measurements
OG0005.8
OG0015.7
Other Diagnostic Tests
Title
Measurements
OG0006.6
OG0015.7
Prescribed Medication
Title
Measurements
OG00034.1
OG00129.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test controlling for investigator.
0.261
P-value for participants reporting use of primary doctor
95
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test controlling for investigator.
0.868
P-value for participants reporting use of specialist
95
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test controlling for investigator.
0.495
P-value for participants reporting other diagnostic tests
95
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test controlling for investigator.
0.189
P-value for participants reporting prescribed medication
95
Superiority or Other
Units
Counts
Participants
OG000172
OG001180
Title
Denominators
Categories
Use of Primary Doctor
Title
Measurements
OG00027.3
OG00124.4
Use of Specialist
Title
Measurements
OG00014.0
OG00113.3
Use of ER or Urgent Care: Other Reason
Title
Measurements
OG0005.8
OG0015.6
Special Scans/Tests
Title
Measurements
OG0005.2
OG0013.3
Other Diagnostic Tests
Title
Measurements
OG00019.2
OG00115.6
Prescribed Medications
Title
Measurements
OG00039.5
OG00135.0
Units
Counts
Participants
OG000247
OG001242
Title
Denominators
Categories
Suicidal ideation
Title
Measurements
OG0007.3
OG0018.3
Suicidal behavior
Title
Measurements
OG0000.0
OG0010.0
Suicidal acts
Title
Measurements
OG0000.0
OG0010.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.737
P-value for suicidal ideation
95
Superiority or Other
Units
Counts
Participants
OG000188
OG001207
Title
Denominators
Categories
Suicidal ideation
Title
Measurements
OG0005.9
OG0016.8
Suicidal behavior
Title
Measurements
OG0001.1
OG0010.5
Suicidal acts
Title
Measurements
OG0000.0
OG0010.5
OG000
246
OG001242
Title
Denominators
Categories
Supine systolic
Title
Measurements
OG0001.45± 0.708
OG001-1.57± 0.683
Supine diastolic
Title
Measurements
OG0003.54± 0.527
OG001-0.64± 0.510
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
0.002
P-value for change in supine systolic blood pressure
95
Superiority or Other
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
<0.001
P-value for change in supine diastolic blood pressure
95
Superiority or Other
Counts
Participants
OG000188
OG001207
Title
Denominators
Categories
Supine systolic
Title
Measurements
OG0000.52± 1.017
OG0012.55± 1.064
Supine diastolic
Title
Measurements
OG000-0.68± 0.724
OG0012.25± 0.710
246
OG001242
Title
Denominators
Categories
Title
Measurements
OG0009.72± 0.677
OG001-0.11± 0.655
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.