Relapse Prevention Study Of Desvenlafaxine Succinate Sust... | NCT00887224

ID	Type	Description	Link
B2061004

Relapse Prevention Study Of Desvenlafaxine Succinate Sust... | NCT00887224 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desvenlafaxine succinate sustained release 50 mg	Experimental		Drug: Desvenlafaxine succinate sustained release 50 mg Drug: Desvenlafaxine succinate sustained release 25 mg
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desvenlafaxine succinate sustained release 50 mg	Drug	50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185	Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).	Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale	CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.	Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Beverly Hills	California	90210	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26693033	Derived	Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy of Desvenlafaxine 50 mg/d Versus Placebo in the Long-Term Treatment of Major Depressive Disorder: A Randomized, Double-Blind Trial. Prim Care Companion CNS Disord. 2015 Aug 27;17(4):10.4088/PCC.14m01711. doi: 10.4088/PCC.14m01711. eCollection 2015.
26644956	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DVS SR 50 mg (Open-label Phase)	Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG00046 subjects FG0010 subjects FG0020 subjects
Failed to return		FG0006 subjects FG0010 subjects FG0020 subjects
Lack of Efficacy		FG00026 subjects FG0010 subjects FG0020 subjects
Lost to Follow-up		FG00016 subjects FG0010 subjects FG0020 subjects
Other		FG0001 subjects FG0010 subjects FG0020 subjects
Protocol Violation		FG00012 subjects FG0010 subjects FG0020 subjects
Withdrawal by Subject		FG00015 subjects FG0010 subjects FG0020 subjects

Between OLR and OLS Phases

Type	Comment	Milestone Data
STARTED		FG000752 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG000659 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG00093 subjects FG0010 subjects FG0020 subjects

Open-label Stability (OLS) Phase

Type	Comment	Milestone Data
STARTED		FG000659 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG000576 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG00083 subjects FG0010 subjects FG0020 subjects

Type	Comment	Reasons
Adverse Event		FG00022 subjects FG0010 subjects FG0020 subjects
Failed to return		FG000

Between OLS and DB Phases

Type	Comment	Milestone Data
STARTED		FG000576 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG000548 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG00028 subjects FG0010 subjects FG0020 subjects

OL Taper Phase / OL Follow Up

Type	Comment	Milestone Data
STARTED		FG000307 subjectsCould have entered 7-day taper period at any time during either the OLR phase or OLS phase. FG0010 subjects FG0020 subjects
Discontinued Open-label Taper		FG000144 subjectsCould have discontinued at any time during OL taper phase or OL Follow-up (7 days after last dose). FG0010 subjects FG0020 subjects
COMPLETED		FG000163 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG000144 subjects FG0010 subjects FG0020 subjects

Type	Comment	Reasons
Adverse Event		FG00028 subjects FG0010 subjects FG0020 subjects
Failed to return		FG000

Double-blind (DB) Phase

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG001276 subjects2 participants randomized in error to DB, then entered OL Taper; counted in OL Taper and DB phases. FG002272 subjects
COMPLETED		FG0000 subjects FG001176 subjects FG002210 subjects
NOT COMPLETED		FG0000 subjects FG001100 subjects FG00262 subjects

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0017 subjects FG0022 subjects
Failed to return		FG000

DB Taper Phase / Post Study Follow Up

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG001267 subjectsDouble-blind participants (DBp) could have entered 7-day taper period at any time during DB phase. FG002265 subjects
Did Not Enter DB Taper		FG0000 subjects FG0019 subjects FG0027 subjects
Discontinued DB Taper		FG0000 subjects FG00141 subjectsDBp could have discontinued at anytime during DB taper period or Follow-up (7 days after last dose). FG00230 subjects
COMPLETED		FG0000 subjects FG001226 subjects FG002235 subjects
NOT COMPLETED		FG0000 subjects FG00141 subjects FG00230 subjects

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0015 subjects FG0020 subjects
Failed to return		FG000

Arm/Group Information

ID	Title	Description
BG000	DVS SR 50 mg (Open-label Phase)	DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
BG001	Placebo (Double-blind Phase)	Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase. Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
BG002	DVS SR 50 mg (Double-blind Phase)	Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase. DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

OL Baseline All Enrolled Population

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.98± 13.25 BG001NA± NABaseline Age reported for participants entering the Open-label phase at study start. BG002NA± NABaseline Age reported for participants entering the Open-label phase at study start.

Gender

OL Baseline All Enrolled Population. Baseline Gender reported for participants entering the Open-label phase at study start.

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000608 BG0010 BG002

Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale

CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Outcome measure CGI-I results reported for DB phase; CGI-I baseline=DB baseline.

Number

participants

Title

Denominators

Categories

1=very much improved

Title	Measurements
	BG0000 BG001

Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Total Score

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression.

Mean

Standard Deviation

scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG000NA± NAOutcome measure HAM-D17 results reported for DB phase; HAM-D17 baseline=DB baseline. BG001

Number of participants with remission based on HAM-D17 score

HAM-D17: standardized, clinician-administered rating scale that assesses 17 items associated with major depression (such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items scored on 3 point scale (0=none/absent to 2=most severe) and 8 items scored on 5 point scale (0=none/absent to 4=most severe) for maximum total score of 50; higher score indicates more depression. Remission (Yes or No) based on HAMD-17 total score ≤7. Outcome measure HAM-D17 Remission results reported for DB phase; HAM-D17 Remission baseline=DB baseline.

Number

participants

Title

Denominators

Categories

Remission=No

Title	Measurements
	BG0000 BG001

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

Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185

Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).

All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.

Posted

Number

percent estimated probability

Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Units	Counts
Participants	OG000276 OG001272

Title

Denominators

Categories

Title	Measurements
	OG00030.2 OG00114.3

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		Log Rank		<0.001	Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.						95						No	Superiority or Other

Secondary

Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale

All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).

Posted

Number

participants

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase

CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).

All Randomized population. N=number of participants with analyzable data at observation.

Posted

Mean

Standard Error

scores on a scale

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Units	Counts
Participants

Secondary

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase

All Randomized population. N=number of participants with analyzable data at observation.

Posted

Mean

Standard Error

scores on a scale

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Secondary

Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase

HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.

All Randomized population. N=number of participants with analyzable data at observation.

Posted

Mean

Standard Error

scores on a scale

Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Secondary

Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26

All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).

Posted

Number

participants

Double-blind phase Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Secondary

Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index

WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.

All Randomized population. N=number of participants with analyzable data at observation.

Posted

Mean

Standard Error

scores on a scale

Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Secondary

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase

WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.

All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.

Posted

Mean

Standard Error

scores on a scale

Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)

ID	Title	Description
OG000	Placebo	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
OG001	DVS SR 50 mg	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DVS SR 50 mg (Open-label Response Phase)	DVS SR 50 mg PO QD for 8 weeks.	9	874	609	874
EG001	DVS SR 50 mg (Open Label Stability Phase)	DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.	6	659	36	659
EG002	DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)	Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.	4	326	8	326
EG003	Placebo (Double-blind Phase)	Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.	7	276	81	276
EG004	DVS SR 50 mg (Double-blind Phase)	DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.	8	272	55	272
EG005	Placebo (DB Taper / DB Post Study Follow Up)	Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.	1	276	14	276
EG006	DVS SR 50 mg (DB Taper / DB Post Study Follow Up)	Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.	1	272	23	272

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrioventricular block second degree	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG0030 affected276 at risk EG004
Subcutaneous abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0002 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Aggression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Depressive symptom	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0002 affected874 at risk EG0012 affected659 at risk EG0021 affected326 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0002 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment		EG0001 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0021 affected326 at risk EG003
Self injurious behaviour	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0011 affected659 at risk EG0020 affected326 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Genital infection bacterial	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	Outcome: Death	EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0021 affected326 at risk EG003
Intrauterine death	Pregnancy, puerperium and perinatal conditions	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0021 affected326 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment		EG0000 affected874 at risk EG0010 affected659 at risk EG0021 affected326 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00051 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG0030 affected276 at risk EG0040 affected272 at risk EG0050 affected276 at risk EG0060 affected272 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00044 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG000104 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG000184 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00062 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG000160 affected874 at risk EG00136 affected659 at risk EG0028 affected326 at risk EG003
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG00045 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG00044 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00050 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected874 at risk EG0010 affected659 at risk EG0020 affected326 at risk EG003

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D008055	Lipids

Title

Denominators

Categories

DB Week 1: 1=very much improved

Title	Measurements
	OG0009 OG0013

DB Week 1: 2=much improved

Title	Measurements
	OG0001 OG0013

DB Week 1: 3=minimally improved

Title	Measurements
	OG00012 OG00119

DB Week 1: 4=no change

Title	Measurements
	OG000227 OG001212

DB Week 1: 5=minimally worse

Title	Measurements
	OG00016 OG00120

DB Week 1: 6=much worse

Title	Measurements
	OG0002 OG0013

DB Week 1: 7=very much worse

Title	Measurements
	OG0000 OG0011

DB Week 2: 1=very much improved

Title	Measurements
	OG0007 OG0013

DB Week 2: 2=much improved

Title	Measurements
	OG0005 OG0016

DB Week 2: 3=minimally improved

Title	Measurements
	OG00015 OG00124

DB Week 2: 4=no change

Title	Measurements
	OG000183 OG001197

DB Week 2: 5=minimally worse

Title	Measurements
	OG00032 OG00125

DB Week 2: 6=much worse

Title	Measurements
	OG00015 OG0014

DB Week 2: 7=very much worse

Title	Measurements
	OG0000 OG0010

DB Week 3: 1=very much improved

Title	Measurements
	OG0005 OG0016

DB Week 3: 2=much improved

Title	Measurements
	OG0005 OG0018

DB Week 3: 3=minimally improved

Title	Measurements
	OG00017 OG00127

DB Week 3: 4=no change

Title	Measurements
	OG000169 OG001185

DB Week 3: 5=minimally worse

Title	Measurements
	OG00045 OG00124

DB Week 3: 6=much worse

Title	Measurements
	OG0006 OG0012

DB Week 3: 7=very much worse

Title	Measurements
	OG0000 OG0010

DB Week 4: 1=very much improved

Title	Measurements
	OG0005 OG0018

DB Week 4: 2=much improved

Title	Measurements
	OG0006 OG0017

DB Week 4: 3=minimally improved

Title	Measurements
	OG00020 OG00128

DB Week 4: 4=no change

Title	Measurements
	OG000169 OG001181

DB Week 4: 5=minimally worse

Title	Measurements
	OG00039 OG00120

DB Week 4: 6=much worse

Title	Measurements
	OG0006 OG0012

DB Week 4: 7=very much worse

Title	Measurements
	OG0001 OG0011

DB Week 6: 1=very much improved

Title	Measurements
	OG0006 OG0019

DB Week 6: 2=much improved

Title	Measurements
	OG0005 OG00111

DB Week 6: 3=minimally improved

Title	Measurements
	OG00020 OG00131

DB Week 6: 4=no change

Title	Measurements
	OG000153 OG001174

DB Week 6: 5=minimally worse

Title	Measurements
	OG00040 OG00116

DB Week 6: 6=much worse

Title	Measurements
	OG00014 OG0016

DB Week 6: 7=very much worse

Title	Measurements
	OG0000 OG0010

DB Week 10: 1=very much improved

Title	Measurements
	OG0003 OG0017

DB Week 10: 2=much improved

Title	Measurements
	OG0004 OG0019

DB Week 10: 3=minimally improved

Title	Measurements
	OG00019 OG00128

DB Week 10: 4=no change

Title	Measurements
	OG000140 OG001161

DB Week 10: 5=minimally worse

Title	Measurements
	OG00046 OG00128

DB Week 10: 6=much worse

Title	Measurements
	OG0009 OG0018

DB Week 10: 7=very much worse

Title	Measurements
	OG0001 OG0011

DB Week 14: 1=very much improved

Title	Measurements
	OG0003 OG0014

DB Week 14: 2=much improved

Title	Measurements
	OG0005 OG00110

DB Week 14: 3=minimally improved

Title	Measurements
	OG00016 OG00129

DB Week 14: 4=no change

Title	Measurements
	OG000124 OG001159

DB Week 14: 5=minimally worse

Title	Measurements
	OG00049 OG00125

DB Week 14: 6=much worse

Title	Measurements
	OG00010 OG0013

DB Week 14: 7=very much worse

Title	Measurements
	OG0000 OG0010

DB Week 18: 1=very much improved

Title	Measurements
	OG0006 OG0017

DB Week 18: 2=much improved

Title	Measurements
	OG0006 OG0016

DB Week 18: 3=minimally improved

Title	Measurements
	OG00012 OG00128

DB Week 18: 4=no change

Title	Measurements
	OG000117 OG001151

DB Week 18: 5=minimally worse

Title	Measurements
	OG00039 OG00124

DB Week 18: 6=much worse

Title	Measurements
	OG00012 OG0016

DB Week 18: 7=very much worse

Title	Measurements
	OG0000 OG0011

DB Week 22: 1=very much improved

Title	Measurements
	OG0007 OG0018

DB Week 22: 2=much improved

Title	Measurements
	OG0004 OG0016

DB Week 22: 3=minimally improved

Title	Measurements
	OG00013 OG00129

DB Week 22: 4=no change

Title	Measurements
	OG000116 OG001139

DB Week 22: 5=minimally worse

Title	Measurements
	OG00030 OG00128

DB Week 22: 6=much worse

Title	Measurements
	OG00013 OG0015

DB Week 22: 7=very much worse

Title	Measurements
	OG0001 OG0010

DB Week 26: 1=very much improved

Title	Measurements
	OG0007 OG0019

DB Week 26: 2=much improved

Title	Measurements
	OG0007 OG00110

DB Week 26: 3=minimally improved

Title	Measurements
	OG00013 OG00129

DB Week 26: 4=no change

Title	Measurements
	OG000105 OG001135

DB Week 26: 5=minimally worse

Title	Measurements
	OG00031 OG00122

DB Week 26: 6=much worse

Title	Measurements
	OG00010 OG0015

DB Week 26: 7=very much worse

Title	Measurements
	OG0001 OG0010

Title

Denominators

Categories

Change from Baseline at DB Week 1

Title	Measurements
	OG0000.03± 0.03 OG0010.03± 0.03

Change from Baseline at DB Week 2

Title	Measurements
	OG0000.18± 0.04 OG0010.09± 0.04

Change from Baseline at DB Week 3

Title	Measurements
	OG0000.21± 0.04 OG0010.07± 0.04

Change from Baseline at DB Week 4

Title	Measurements
	OG0000.23± 0.05 OG0010.06± 0.05

Change from Baseline at DB Week 6

Title	Measurements
	OG0000.32± 0.05 OG0010.06± 0.05

Change from Baseline at DB Week 10

Title	Measurements
	OG0000.39± 0.06 OG0010.11± 0.06

Change from Baseline at DB Week 14

Title	Measurements
	OG0000.38± 0.05 OG0010.05± 0.05

Change from Baseline at DB Week 18

Title	Measurements
	OG0000.42± 0.06 OG0010.09± 0.06

Change from Baseline at DB Week 22

Title	Measurements
	OG0000.56± 0.07 OG0010.13± 0.07

Change from Baseline at DB Week 26

Title	Measurements
	OG0000.53± 0.06 OG0010.09± 0.06

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Adjusted difference from placebo: Week 1	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.9627	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	-0.00	2-Sided	95	-0.09	0.08	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 2	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.1046	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.09	2-Sided	95	-0.02	0.21	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 3	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0228	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.13	2-Sided	95	0.02	0.25	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 4	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0064	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.17	2-Sided	95	0.05	0.29	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 6	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.25	2-Sided	95	0.11	0.39	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 10	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.28	2-Sided	95	0.12	0.43	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.33	2-Sided	95	0.19	0.47	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 18	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.33	2-Sided	95	0.17	0.49	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 22	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.43	2-Sided	95	0.25	0.62	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.44	2-Sided	95	0.28	0.61	No	Superiority or Other

Title

Denominators

Categories

Change from Baseline at DB Week 1

Title	Measurements
	OG0000.28± 0.17 OG0010.25± 0.17

Change from Baseline at DB Week 2

Title	Measurements
	OG0001.40± 0.24 OG0010.53± 0.24

Change from Baseline at DB Week 3

Title	Measurements
	OG0001.32± 0.22 OG0010.45± 0.23

Change from Baseline at DB Week 4

Title	Measurements
	OG0001.50± 0.24 OG0010.11± 0.24

Change from Baseline at DB Week 6

Title	Measurements
	OG0001.94± 0.28 OG0010.31± 0.28

Change from Baseline at DB Week 10

Title	Measurements
	OG0002.37± 0.32 OG0010.69± 0.31

Change from Baseline at DB Week 14

Title	Measurements
	OG0002.66± 0.30 OG0010.62± 0.30

Change from Baseline at DB Week 18

Title	Measurements
	OG0002.51± 0.33 OG0010.56± 0.32

Change from Baseline at DB Week 22

Title	Measurements
	OG0003.22± 0.37 OG0010.92± 0.36

Change from Baseline at DB Week 26

Title	Measurements
	OG0003.12± 0.36 OG0010.77± 0.34

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Adjusted difference from placebo: Week 1	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.8853	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.03	2-Sided	95	-0.41	0.47	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 2	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0081	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.88	2-Sided	95	0.23	1.52	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 3	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0038	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.88	2-Sided	95	0.28	1.47	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 4	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.39	2-Sided	95	0.76	2.03	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 6	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.63	2-Sided	95	0.86	2.39	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 10	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.68	2-Sided	95	0.83	2.54	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	2.04	2-Sided	95	1.23	2.86	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 18	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.95	2-Sided	95	1.06	2.84	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 22	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	2.30	2-Sided	95	1.31	3.30	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	2.35	2-Sided	95	1.39	3.32	No	Superiority or Other

Title

Denominators

Categories

Change from baseline at DB Week1

Title	Measurements
	OG0000.03± 0.10 OG0010.01± 0.10

Change from baseline at DB Week 2

Title	Measurements
	OG0000.66± 0.14 OG0010.13± 0.14

Change from baseline at DB Week 3

Title	Measurements
	OG0000.72± 0.14 OG0010.14± 0.14

Change from baseline at DB Week 4

Title	Measurements
	OG0000.92± 0.15 OG0010.03± 0.15

Change from baseline at DB Week 6

Title	Measurements
	OG0001.04± 0.17 OG0010.16± 0.16

Change from baseline at DB Week 10

Title	Measurements
	OG0001.41± 0.19 OG0010.33± 0.18

Change from baseline at DB Week 14

Title	Measurements
	OG0001.47± 0.17 OG0010.34± 0.17

Change from baseline at DB Week 18

Title	Measurements
	OG0001.51± 0.20 OG0010.21± 0.19

Change from baseline at DB Week 22

Title	Measurements
	OG0001.68± 0.20 OG0010.45± 0.19

Change from baseline at DB Week 26

Title	Measurements
	OG0001.53± 0.20 OG0010.26± 0.19

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Adjusted difference from placebo: Week 1	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.9142	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.01	2-Sided	95	-0.24	0.27	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 2	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0069	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.53	2-Sided	95	0.15	0.91	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 3	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0023	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.58	2-Sided	95	0.21	0.95	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 4	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.89	2-Sided	95	0.49	1.28	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 6	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	0.88	2-Sided	95	0.43	1.32	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 10	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.08	2-Sided	95	0.58	1.58	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.12	2-Sided	95	0.66	1.58	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 18	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.30	2-Sided	95	0.76	1.83	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 22	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.23	2-Sided	95	0.70	1.76	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.27	2-Sided	95	0.75	1.79	No	Superiority or Other

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	Wald 95% CI for adjusted odds ratio.	Regression, Logistic		<0.0001	Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.	Adjusted odds ratio	2.85			2-Sided	95	1.93	4.20				No	Superiority or Other

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	Adjusted difference from placebo: Week 14	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	-2.14			2-Sided	95	-3.03	-1.24				No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	-2.32			2-Sided	95	-3.29	-1.34				No	Superiority or Other

Title

Denominators

Categories

Change from Bsl at DB Week 14: Absenteeism

Title	Measurements
	OG0001.64± 1.72 OG0010.62± 1.87

Change from Bsl at DB Week 14: Presenteeism

Title	Measurements
	OG0009.35± 2.30 OG0012.44± 2.55

Change from Bsl DB Week 14: Work productivity loss

Title	Measurements
	OG0009.66± 2.48 OG0012.19± 2.75

Change from Bsl at DB Week 14: Activity impairment

Title	Measurements
	OG00011.02± 1.62 OG0013.45± 1.66

Change from Bsl at DB Week 26: Absenteeism

Title	Measurements
	OG0000.43± 2.05 OG0010.77± 2.08

Change from Bsl at DB Week 26: Presenteeism

Title	Measurements
	OG0007.75± 2.35 OG001-0.49± 2.41

Change from Bsl DB Week 26: Work productivity loss

Title	Measurements
	OG0008.47± 2.56 OG001-0.00± 2.63

Change from Bsl at DB Week 26: Activity impairment

Title	Measurements
	OG0009.67± 1.75 OG0012.05± 1.69

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Adjusted difference from placebo: Week 14 Absenteeism	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.6772	P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	1.02	2-Sided	95	-3.82	5.87	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26 Absenteeism	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.9059	P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	-0.33	2-Sided	95	-5.91	5.24	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14 Presenteeism	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0414	P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	6.91	2-Sided	95	0.27	13.55	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26 Presenteeism	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0129	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	8.24	2-Sided	95	1.77	14.71	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14 Work Productivity Loss	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0402	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	7.48	2-Sided	95	0.34	14.61	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26 Work Productivity Loss	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	0.0187	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	8.48	2-Sided	95	1.43	15.53	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 14 Activity Impairment	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	7.57	2-Sided	95	3.33	11.80	No	Superiority or Other
OG000 OG001	Adjusted difference from placebo: Week 26 Activity Impairment	Mixed Models Analysis	Mixed-effects model for repeated measures (MMRM).	<0.001	P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.	Mean Difference (Final Values)	7.62	2-Sided	95	3.14	12.10	No	Superiority or Other

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders