Study of the Safety and Efficacy of OPC-34712 as Adjuncti... | NCT00797966

Study of the Safety and Efficacy of OPC-34712 as Adjuncti... | NCT00797966 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental	OPC-34712 + ADT	Drug: OPC-34712 Drug: ADT
2	Placebo Comparator	Placebo + ADT	Drug: Placebo Drug: ADT

Name	Type	Description	Arm Group Labels	Other Names
OPC-34712	Drug	Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.	The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.	Week 8 to Week 14

Secondary Outcomes

Measure	Description	Time Frame
Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.	CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Clinical Research Medical Group		Arcadia	California	91007	United States
Southwestern Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30508090	Derived	Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
FG001	OPC-34712 0.5 ± 0.25 mg Low Dose

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG00433 subjects FG0050 subjects
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Met withdrawal criteria		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Physician Decision		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Protocol deviation		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Phase B

Type	Comment	Milestone Data
STARTED		FG00062 subjectsRandomized participants. FG001120 subjectsRandomized participants. FG002121 subjectsRandomized participants. FG003126 subjectsRandomized participants. FG0040 subjects FG0050 subjects
COMPLETED		FG00051 subjects FG001102 subjects FG002100 subjects FG003110 subjects FG004
NOT COMPLETED		FG00011 subjects FG00118 subjects FG00221 subjects FG00316 subjects FG004

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0011 subjects FG0023 subjects FG003

Phase A+

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG005235 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
BG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
BG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
BG003	Placebo	The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
BG004	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

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00043.9± 10.8 BG00144.0± 11.8 BG00243.7± 11.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00041 BG00186 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

Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.

The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.

Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG003	Placebo	The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Units	Counts
Participants	OG00062 OG001119 OG002118 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-6.62± 0.99 OG001-6.46± 0.73 OG002-8.23± 0.74 OG003

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 OG003	The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.	ANCOVA		0.6551		Mean Difference (Final Values)	-0.53			2-Sided	95	-2.87	1.81				No	Superiority or Other

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.

CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.

ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG002

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).

The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer.

Posted

Least Squares Mean

Standard Error

Percentage of maximum possible score

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).

The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose

Secondary

Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to each of Week 9, 10, 11, 12 and 13.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to each of Week 9, 10, 11, 12 and 13.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG002	OPC-34712 1.5 ± 0.5 mg High Dose

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.

The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to each of Week 9, 10, 11, 12, 13 and 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.

The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the "best" rating and the highest score (2 or 4) is the "worst" rating. The possible total scores are from 0 to 52.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 8 to Week 14

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
OG002

Secondary

Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.

CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.

Posted

Mean

Standard Deviation

Units on a scale

Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination

Secondary

Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).

A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).

Posted

Number

Percentage of participants

Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).

A MADRS remission was defined as MADRS Total Score </= 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).

Posted

Number

Percentage of participants

Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Secondary

Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).

CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].

Posted

Number

percentage of participants

Week 9, 10, 11, 12, 13 and 14.

ID	Title	Description
OG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
OG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
OG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	OPC-34712 0.15 mg Fixed Dose	The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.	0	62	21	62
EG001	OPC-34712 0.5 ± 0.25 mg Low Dose	The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.	0	120	37	120
EG002	OPC-34712 1.5 ± 0.5 mg High Dose	The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.	2	121	47	121
EG003	Placebo	The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.	1	126	37	126

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Radius fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected62 at risk EG0010 affected120 at risk EG0021 affected121 at risk EG0030 affected126 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected62 at risk EG0010 affected120 at risk EG0021 affected121 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected62 at risk EG0010 affected120 at risk EG0020 affected121 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected62 at risk EG0010 affected120 at risk EG0021 affected121 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected62 at risk EG0010 affected120 at risk EG00210 affected121 at risk EG0035 affected126 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected62 at risk EG0017 affected120 at risk EG0022 affected121 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected62 at risk EG0017 affected120 at risk EG0025 affected121 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0004 affected62 at risk EG00110 affected120 at risk EG0027 affected121 at risk EG003
Weight increased	Investigations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected62 at risk EG0017 affected120 at risk EG0029 affected121 at risk EG003
Akathisia	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected62 at risk EG0016 affected120 at risk EG00210 affected121 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected62 at risk EG0013 affected120 at risk EG0024 affected121 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected62 at risk EG0011 affected120 at risk EG0025 affected121 at risk EG003
Headache	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected62 at risk EG0019 affected120 at risk EG0026 affected121 at risk EG003

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D015057	1-Naphthylamine
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D010636	Phenols
D001555	Benzene Derivatives
D008055	Lipids
D010627	Phenethylamines
D005021	Ethylamines

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	ANCOVA	0.4166	Mean Difference (Final Values)	-0.13	2-Sided	95	-0.43	0.18	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo	No	Superiority or Other
OG001 OG003	ANCOVA	0.4193	Mean Difference (Final Values)	-0.10	2-Sided	95	-0.35	0.15	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG002 OG003	ANCOVA	0.0064	Mean Difference (Final Values)	-0.35	2-Sided	95	-0.60	-0.10	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	ANCOVA	0.4490	Mean Difference (Final Values)	1.68	2-Sided	95	-2.67	6.02	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG001 OG003	ANCOVA	0.7412	Mean Difference (Final Values)	0.61	2-Sided	95	-3.02	4.24	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG002 OG003	ANCOVA	0.4070	Mean Difference (Final Values)	1.54	2-Sided	95	-2.10	5.17	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	ANCOVA	0.4954	Mean Difference (Final Values)	-0.22	2-Sided	95	-0.86	0.42	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG001 OG003	ANCOVA	0.4902	Mean Difference (Final Values)	-0.19	2-Sided	95	-0.73	0.35	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG002 OG003	ANCOVA	0.0161	Mean Difference (Final Values)	-0.66	2-Sided	95	-1.20	-0.12	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other

Title

Denominators

Categories

Week 9 (N=61,117,116,121)

Title	Measurements
	OG000-2.13± 5.22 OG001-3.00± 5.13 OG002-2.75± 5.32 OG003-2.48± 5.43

Week 10 (N=62,119,118,126)

Title	Measurements
	OG000-3.69± 5.34 OG001-3.78± 6.27 OG002-4.97± 6.48 OG003

Week 11 (N=62,119,118,126)

Title	Measurements
	OG000-5.53± 7.24 OG001-5.71± 7.15 OG002-5.88± 7.09 OG003

Week 12 (N=62,119,118,126)

Title	Measurements
	OG000-6.97± 7.65 OG001-6.31± 6.72 OG002-7.01± 7.58 OG003

Week 13 (N=62,119,118,126)

Title	Measurements
	OG000-6.90± 7.71 OG001-6.76± 7.20 OG002-7.18± 7.64 OG003

Title

Denominators

Categories

Week 9 (N=62,117,116,121)

Title	Measurements
	OG000-0.21± 0.60 OG001-0.26± 0.57 OG002-0.33± 0.64 OG003-0.21± 0.58

Week 10 (N=62,119,118,126)

Title	Measurements
	OG000-0.42± 0.74 OG001-0.39± 0.77 OG002-0.61± 0.91 OG003

Week 11 (N=62,119,118,126)

Title	Measurements
	OG000-0.53± 0.95 OG001-0.53± 0.84 OG002-0.69± 0.92 OG003

Week 12 (N=62,119,118,126)

Title	Measurements
	OG000-0.76± 1.02 OG001-0.66± 0.87 OG002-0.86± 1.00 OG003

Week 13 (N=62,119,118,126)

Title	Measurements
	OG000-0.74± 1.09 OG001-0.78± 0.95 OG002-0.88± 1.01 OG003

Title

Denominators

Categories

Week 9 (N=61, 117,116,121)

Title	Measurements
	OG000-0.98± 7.28 OG001-1.88± 6.60 OG002-2.04± 5.93 OG003-0.98± 7.58

Week 10 (N=62, 119, 118, 126)

Title	Measurements
	OG000-2.13± 8.02 OG001-2.58± 7.37 OG002-4.08± 7.25 OG003

Week 11 (N=62, 119, 118, 126)

Title	Measurements
	OG000-3.58± 7.81 OG001-3.41± 7.88 OG002-4.82± 7.96 OG003

Week 12 (N=62, 119, 118, 126)

Title	Measurements
	OG000-5.11± 9.42 OG001-3.77± 8.45 OG002-5.77± 9.26 OG003

Week 13 (N=62, 119, 118, 126)

Title	Measurements
	OG000-5.34± 9.15 OG001-5.22± 8.72 OG002-5.65± 8.84 OG003

Week 14 (N=62, 119, 118, 126)

Title	Measurements
	OG000-5.55± 9.65 OG001-4.96± 9.37 OG002-6.74± 9.76 OG003

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	ANCOVA	0.5953	Mean Difference (Final Values)	-0.54	2-Sided	95	-2.54	1.46	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG001 OG003	ANCOVA	0.9479	Mean Difference (Final Values)	-0.05	2-Sided	95	-1.66	1.55	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other
OG002 OG003	ANCOVA	0.0919	Mean Difference (Final Values)	-1.36	2-Sided	95	-2.95	0.22	Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.	No	Superiority or Other

Title

Denominators

Categories

Week 9 (N=62, 117, 116, 121)

Title	Measurements
	OG0003.39± 0.86 OG0013.30± 0.79 OG0023.20± 0.80 OG0033.31± 0.79

Week 10 (N=62, 119, 118, 126)

Title	Measurements
	OG0003.16± 0.94 OG0013.19± 0.90 OG0022.95± 0.93 OG003

Week 11 (N=62, 119, 118, 126)

Title	Measurements
	OG0002.94± 0.94 OG0013.02± 0.98 OG0022.80± 0.92 OG003

Week 12 (N=62, 119, 118, 126)

Title	Measurements
	OG0002.87± 1.06 OG0012.90± 0.99 OG0022.70± 1.03 OG003

Week 13 (N=62, 119, 118, 126)

Title	Measurements
	OG0002.85± 1.13 OG0012.76± 1.02 OG0022.64± 1.06 OG003

Week 14 (N=62, 119, 118, 126)

Title	Measurements
	OG0002.74± 1.16 OG0012.78± 1.02 OG0022.52± 1.08 OG003

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.3998	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.8838	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.4012	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG000 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.6131	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.5964	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.2540	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG000 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.8524	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.6969	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.3108	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG000 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.8719	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.6105	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0709	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG000 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.9574	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.2310	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.0672	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG000 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.8441	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG001 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.6741	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other
OG002 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.0183	Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.	No	Superiority or Other

Title

Denominators

Categories

Week 9 (N=61, 117, 116, 121)

Title	Measurements
	OG0004.92 OG0016.84 OG0022.59 OG0038.26

Week 10 (N=62, 119, 118, 126)

Title	Measurements
	OG0008.06 OG0018.40 OG00211.0 OG003

Week 11 (N=62, 119, 118, 126)

Title	Measurements
	OG00019.4 OG00115.1 OG00218.6 OG003

Week 12 (N=62, 119, 118, 126)

Title	Measurements
	OG00030.6 OG00115.1 OG00225.4 OG003

Week 13 (N=62, 119, 118, 126)

Title	Measurements
	OG00024.2 OG00122.7 OG00225.4 OG003

Week 14 (N=62, 119, 118, 126)

Title	Measurements
	OG00027.4 OG00120.2 OG00234.7 OG003

Group IDs	Group Description	Statistical Method	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 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.3007	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.49	2-Sided	95	0.12	1.93	No	Superiority or Other
OG001 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.8812	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.94	2-Sided	95	0.42	2.10	No	Superiority or Other
OG002 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.0553	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.32	2-Sided	95	0.10	1.07	No	Superiority or Other
OG000 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.6051	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.78	2-Sided	95	0.30	2.05	No	Superiority or Other
OG001 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.8264	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.92	2-Sided	95	0.46	1.85	No	Superiority or Other
OG002 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.8690	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.06	2-Sided	95	0.54	2.10	No	Superiority or Other
OG000 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.3441	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.35	2-Sided	95	0.74	2.44	No	Superiority or Other
OG001 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.6375	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.14	2-Sided	95	0.67	1.94	No	Superiority or Other
OG002 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.3135	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.31	2-Sided	95	0.78	2.21	No	Superiority or Other
OG000 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0035	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	2.35	2-Sided	95	1.32	4.18	No	Superiority or Other
OG001 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.4358	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.27	2-Sided	95	0.70	2.31	No	Superiority or Other
OG002 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0063	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	2.02	2-Sided	95	1.20	3.41	No	Superiority or Other
OG000 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.3968	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.27	2-Sided	95	0.72	2.23	No	Superiority or Other
OG001 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.2990	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.27	2-Sided	95	0.81	2.00	No	Superiority or Other
OG002 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.1614	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.39	2-Sided	95	0.86	2.25	No	Superiority or Other
OG000 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.3254	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.29	2-Sided	95	0.79	2.12	No	Superiority or Other
OG001 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.9463	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.02	2-Sided	95	0.64	1.62	No	Superiority or Other
OG002 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.0080	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.74	2-Sided	95	1.14	2.65	No	Superiority or Other

Title

Denominators

Categories

Week 9 (N=61, 117, 116, 121)

Title	Measurements
	OG0003.28 OG0011.71 OG0021.72 OG0034.13

Week 10 (N=62, 119, 118, 126)

Title	Measurements
	OG0008.06 OG0015.04 OG00210.2 OG003

Week 11 (N=62, 119, 118, 126)

Title	Measurements
	OG00012.9 OG00110.1 OG00214.4 OG003

Week 12 (N=62, 119, 118, 126)

Title	Measurements
	OG00021.0 OG00110.1 OG00219.5 OG003

Week 13 (N=62, 119, 118, 126)

Title	Measurements
	OG00019.4 OG00116.8 OG00215.3 OG003

Week 14 (N=62, 119, 118, 126)

Title	Measurements
	OG00022.6 OG00115.1 OG00223.7 OG003

Group IDs	Group Description	Statistical Method	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 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.5791	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.59	2-Sided	95	0.09	3.90	No	Superiority or Other
OG001 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.2653	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.43	2-Sided	95	0.10	1.93	No	Superiority or Other
OG002 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.2259	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.39	2-Sided	95	0.08	1.87	No	Superiority or Other
OG000 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.6986	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.83	2-Sided	95	0.32	2.18	No	Superiority or Other
OG001 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.2339	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.61	2-Sided	95	0.28	1.35	No	Superiority or Other
OG002 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.8615	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.07	2-Sided	95	0.53	2.15	No	Superiority or Other
OG000 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.8807	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.06	2-Sided	95	0.51	2.20	No	Superiority or Other
OG001 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.9035	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.96	2-Sided	95	0.52	1.77	No	Superiority or Other
OG002 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.5898		Ratio of Remission Rate	1.19	2-Sided	95	0.64	2.24	No	Superiority or Other
OG000 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0840	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.82	2-Sided	95	0.93	3.58	No	Superiority or Other
OG001 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.9115	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.96	2-Sided	95	0.49	1.88	No	Superiority or Other
OG002 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0522	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.77	2-Sided	95	0.98	3.17	No	Superiority or Other
OG000 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.4997	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.24	2-Sided	95	0.65	2.34	No	Superiority or Other
OG001 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.5846	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.16	2-Sided	95	0.69	1.93	No	Superiority or Other
OG002 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.9602	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	0.99	2-Sided	95	0.55	1.76	No	Superiority or Other
OG000 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.1254	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.62	2-Sided	95	0.87	3.02	No	Superiority or Other
OG001 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.6670	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.13	2-Sided	95	0.65	1.99	No	Superiority or Other
OG002 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.0525	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Remission Rate	1.70	2-Sided	95	0.98	2.93	No	Superiority or Other

Title

Denominators

Categories

Week 9 (N=62, 117, 116, 121)

Title	Measurements
	OG00016.1 OG00111.1 OG00214.7 OG00314.9

Week 10 (N=62, 119, 118, 126)

Title	Measurements
	OG00025.8 OG00117.6 OG00224.6 OG003

Week 11 (N=62, 119, 118, 126)

Title	Measurements
	OG00032.3 OG00129.4 OG00235.6 OG003

Week 12 (N=62, 119, 118, 126)

Title	Measurements
	OG00035.5 OG00133.6 OG00242.4 OG003

Week 13 (N=62, 119, 118, 126)

Title	Measurements
	OG00037.1 OG00137.0 OG00249.2 OG003

Week 14 (N=62, 119, 118, 126)

Title	Measurements
	OG00038.7 OG00137.0 OG00252.5 OG003

Group IDs	Group Description	Statistical Method	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 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.9462	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.98	2-Sided	95	0.52	1.84	No	Superiority or Other
OG001 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.4971	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.80	2-Sided	95	0.43	1.49	No	Superiority or Other
OG002 OG003	Week 9 values presented here.	Cochran-Mantel-Haenszel	0.8118	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.93	2-Sided	95	0.53	1.63	No	Superiority or Other
OG000 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.8323	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.95	2-Sided	95	0.59	1.53	No	Superiority or Other
OG001 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.0930	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.68	2-Sided	95	0.43	1.08	No	Superiority or Other
OG002 OG003	Week 10 values presented here.	Cochran-Mantel-Haenszel	0.5530	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.88	2-Sided	95	0.59	1.32	No	Superiority or Other
OG000 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.8007	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.06	2-Sided	95	0.69	1.61	No	Superiority or Other
OG001 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.8945	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.03	2-Sided	95	0.71	1.49	No	Superiority or Other
OG002 OG003	Week 11 values presented here.	Cochran-Mantel-Haenszel	0.3837	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.17	2-Sided	95	0.83	1.64	No	Superiority or Other
OG000 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.7064	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.09	2-Sided	95	0.72	1.63	No	Superiority or Other
OG001 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.7469	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.06	2-Sided	95	0.74	1.52	No	Superiority or Other
OG002 OG003	Week 12 values presented here.	Cochran-Mantel-Haenszel	0.0832	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.34	2-Sided	95	0.97	1.86	No	Superiority or Other
OG000 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.6611	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.09	2-Sided	95	0.74	1.61	No	Superiority or Other
OG001 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.4435	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.13	2-Sided	95	0.83	1.56	No	Superiority or Other
OG002 OG003	Week 13 values presented here.	Cochran-Mantel-Haenszel	0.0118	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.47	2-Sided	95	1.09	1.98	No	Superiority or Other
OG000 OG003	Week 14 values presented here.	Chi-squared, Corrected	0.5111	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.89	2-Sided	95	0.63	1.26	No	Superiority or Other
OG001 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.4903	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	0.90	2-Sided	95	0.66	1.22	No	Superiority or Other
OG002 OG003	Week 14 values presented here.	Cochran-Mantel-Haenszel	0.0662	Cochran-Mantel-Haenszel general association test controlling for study center.	Ratio of Response Rate	1.28	2-Sided	95	0.98	1.67	No	Superiority or Other

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D000089983	Escitalopram
D005473	Fluoxetine
D017374	Paroxetine
D020280	Sertraline
D000069468	Desvenlafaxine Succinate
D000069470	Venlafaxine Hydrochloride